Abbreviated MRI Screening in Turkish Women Aged 40-69 With Dense Breasts: A Prospective Feasibility Study

Abbreviated MRI Screening in Turkish Women Aged 40-69 With Dense Breasts: A Prospective Feasibility Study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Abbreviated MRI Screening in Turkish Women Aged 40-69 With Dense Breasts: A Prospective Feasibility Study Inci Kizildag Yirgin, Neslihan Cabioglu, Memduh Dursun, Omur Can, and 11 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4717166/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Survival time and quality of life increase with the early diagnosis of breast cancer. We aim to investigate the feasibility of abbreviated protocol (AP) breast magnetic resonance imaging (MRI) screening in women with dense breasts in a screening program in a middle-income country. Methods The study included 649 women selected randomly from 1285 women with type C and D breasts in a screening program, of which 238 underwent an abbreviated breast MRI screening (AP-MRI). The AP-MRI consisted of dynamic series during the first and second post-contrast phases, in addition to axial T1W and axial T2W-fat sat (TRIM) sequences. The reference standard for the study was based on pathology results obtained from biopsies and normal screening mammography results within two years. Results MRI scans of 201 women (84.4%) displayed normal or benign findings (BIRADS-1 and 2). An additional 25 women (10.5%) were recommended for MRI or ultrasound (USG) follow-up (BI-RADS-3) and did not show any progression in the two-year follow-up. The remaining 12 women (5%) were recommended a biopsy (BIRADS-4), of which five were reclassified as BIRADS-3 after a second-look ultrasound. Subsequently, a biopsy of the remaining seven patients. did not reveal any malignancies. They all had a negative two-year follow-up. The main challenges encountered were scheduling AP-MRI screening and compliance of women. Conclusion This study highlights that supplemental AP-MRI screening may not offer universal benefits for all women with dense breasts. The use of AP breast MRI could potentially lead to overdiagnosis and unnecessary biopsies, primarily due to false positive findings on MRI scans. Breast Neoplasms Radiology Breast density Mammography Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 INTRODUCTION Breast cancer is the most common cancer type and the second cause of cancer-related mortality in women worldwide, according to the 2020 global cancer statistics ( 1 ). It is known that the survival time and quality of life increase with the early diagnosis of breast cancer ( 2 ). Randomized controlled studies have shown a reduction in mortality of up to 30% when breast cancer screening is performed with mammography (MG), and it is the standard screening method ( 3 – 5 ). The major limitation of MG is the 2-dimensional, anatomic imaging technique that could mask breast cancer in dense breasts. Studies have shown that, within groups of the same age, there are two to six times higher risk of breast cancer in dense breasts than in non-dense breasts ( 6 – 8 ). Therefore, cancer screening in women with dense breasts needs further attention. Whole-breast ultrasound (WBUS) is one of the supplemental screening methods in women with dense breasts. Studies have shown a moderate cancer detection rate (CDR) averaging 2.0-4.7 per 1,000 screened cases ( 9 – 13 ). While the method moderately increases its sensitivity, it is associated with high false-positive rates and short-term follow-up ( 10 , 14 , 15 ). Digital breast tomosynthesis (DBT) is a relatively new technique and has demonstrated better sensitivity and specificity than MG in women with dense breasts. Additionally, a decrease in false-positive rates and an increase in cancer detection rate averaging 1.6 additional cancers per 1000 women screened have been reported ( 16 ). Magnetic resonance imaging (MRI) has been accepted as the most sensitive imaging tool for detecting breast cancer ( 17 , 18 ). The advantages, such as soft tissue resolution and dynamic and multiplanar imaging, can lead to smaller cancers than 5 mm ( 19 – 21 ). The American College of Radiology has broadened its recommendations to encompass women with a personal history of breast cancer, those with dense breast tissue, and individuals under 50 who have received a cancer diagnosis ( 25 ). There was no authority recommending that women with average risk and dense breast structure in the normal population be screened with complete breast MRI until March 2022. European Society of Breast Imaging (EUSOBI) has recently published a new recommendation that suggests supplemental MRI screening for women with extremely dense breasts from age 50–70 at least every four years, preferably every 2 or 3 years, in March 2022 ( 26 ). Many studies have investigated new options to decrease the high costs and scan time of complete diagnostic MRI to make it feasible. Kuhl et al. introduced the abbreviated protocol (AP) for breast MRI, demonstrating equivalent diagnostic accuracy to complete breast MRI in women with dense breasts ( 27 ). Several studies have been published showing the high diagnostic accuracy of AP breast MRI with faster performance and lower cost ( 28 – 36 ). AP breast MRI protocols described in the literature are broadly consistent, with minor variations primarily seen in the T2 and diffusion-weighted series ( 37 – 39 ). Generally, the AP consists of a T1W precontrast, a first post-contrast T1W sequence, a subtracted image, and maximum intensity projection (MIP). Unlike benign lesions, the technique is based on the early enhancement of breast cancers. During the initial phases of dynamic images, background parenchymal enhancement is lower, which can minimize the masking effect in dense breasts. Although there is a national screening program in Turkey, mammographic screenings are mostly opportunistic ( 40 , 41 ). Bahcesehir Breast Cancer Screening Project (BMSCP) is a pilot study and an organized population-based biennial screening program that has been carried out on women aged 40–69 living in the county Bahcesehir of Istanbul between 2009 and 2019 ( 42 ). This screening program investigated the feasibility of a population-based organized breast cancer screening program in Turkey as a middle-income country. In this study, we aimed to investigate the feasibility of AP breast MRI screening in women with dense breasts in the BMSCP. MATERIALS AND METHODS The study was approved by the Institutional Review Board of Marmara University (Application No.: 2007/152, Date: 24.01.2007/01). Informed consent was obtained from those eligible women invited to the study who accepted to participate. Population Digital mammograms were collected from BMSP, which is an organized, population-based, 10-year (2009–2019) mammography screening program in Turkey. During the 10 years, biennially, screening was carried out in 8758 women between ages 40 and 69 living in the region who were registered to the Bahçeşehir Breast Cancer Screening Center between January 2009 and January 2019. A total of 22621 bilateral mammography was recorded in the archival system. In the last year of the screening program (between January 2018 and January 2019), mammography was performed on 3299 women. The number of women with heterogeneous dense and extremely dense breast tissue (type C and D) was 1285. Additional screening AP breast MRI was offered to women randomized in a ratio of 2 to 1. As a result, 629 women were invited to the study for AP MRI. Of those, 387 women did not undergo additional MRI screening for the following reasons: 231 didn’t respond, 145 declined to participate, 9 had claustrophobia, and 2 had contrast agent allergy (Fig. 1 ). Finally, 242 agreed to an MRI screening, but images in 4 MR examinations were inadequate to evaluate following a quality assessment. Finally, 238 patients who have heterogeneous dense and extremely dense breast tissue (type C and D) according to the American College of Radiology (ACR) criteria and negative physical examination with negative mammography results were included in the study. Pathology results obtained with biopsies performed after abbreviated MRI scans and normal screening mammography results within two years were accepted as the reference standard. Mammograms Digital mammography images were obtained using a full-field digital mammographic device (Selenia, Hologic) from the screening center. Two projections, mediolateral oblique and craniocaudal, were obtained for each woman. Two breast radiologists with more than five years of experience independently read mammograms in the screening center. In case of inconsistency between the readers, a third radiologist with more than 20 years of experience interpreted the findings for the final decision. Mammographic findings were evaluated under the guidance of the 4th edition of Breast Imaging-Reporting and Data System (BIRADS) of the ACR because BMSP had already started before the last updated 5th version of BIRADS. MRI findings were evaluated under the guidance of the 5th edition of Breast Imaging-Reporting and Data System of the BIRADS ( 43 ). If a suspicious abnormality or highly suggestive of malignancy (BI-RADS 4 or 5 cases) was detected in the imaging in the final report, the radiologists decided on whether to perform a core needle aspiration biopsy (CNB) guided by ultrasonography (14–16 gauge), or a vacuum assisted large core (11 gauge) stereotactic (VALCS) biopsy. Screening is biennial, giving a window of 24 months for an interval cancer to become symptomatic after a negative screening mammography. The prospectively collected outcome data was entered into a computer database as suggested by ACR. Data on pathologic features, any administered therapies, follow-up, and survival outcomes were gathered from our patient and pathology databases. Magnetic Resonance Imaging AP MRI scans were performed in 2 different radiology centers. All MRI scans were applied using a 1.5 T MR scanner (Symphony, Siemens Medical Solutions), and a dedicated channel phased-array breast coil was used. Before dynamic sequences, an intravenous bolus injection of 0.2 ml/kg (standard dose) gadopentetate dimeglumine (Magnevist; Bayer Schering Pharma, Berlin, Germany) was administered, followed by 20 ml of saline. Each patient underwent AP breast MRI in 1–12 weeks after screening mammography. The AP consists of the dynamic series' first and second post-contrast phases and axial T1W and axial T2W-fat sat (TRIM) sequences (Fig. 2 ). Scan acquisition time was 7–10 minutes. On a pixel-by-pixel basis, unenhanced images were subtracted from contrast-enhanced images, producing a single subtracted post-contrast subtraction sequence. Two dedicated breast radiologists performed image quality assessment, who evaluated the images for fat saturation, artifact severity, and quality of normal anatomic structures as described before ( 37 ). When MRI images were evaluated, normal and benign findings were concluded as BIRADS-1 and 2, the cases MRI or US follow-up was recommended after six months concluded as BIRADS-3 and the patients for whom biopsy was recommended concluded as BIRADS-4. Statistical Analysis Statistical software SPSS 25 was used for analyses (Statistical Package for Social Sciences; SPSS, IBM Corp., Armonk, NY, USA) 17.0 (SPSS Inc., Chicago, IL, USA). Categorical variables were evaluated by the Pearson Chi-square test. Mann-Whitney U test was used to determine the differences between continuous variables. A p-value equal to or less than 0.05 was statistically significant. RESULTS A total of 238 women with type C and D breasts were included in the study. The median age was 44 (min, 40–62), and the mean was 45.5+/- 0.34 years. The physical examination findings of all these women were evaluated as normal. Of those, 14 women were in the extremely dense (ACR type D) group, and 224 were in the heterogeneous dense (ACR type C) group. The screening mammography results were as follows: 88 women had BIRADS-1, and 150 women had BIRADS-2 imaging findings. All patients had an MRI after MMG in a month to 6 months due to the restrictions to organize the appointment in busy diagnostic MRI schedules. Of the MRI scan results, 201 women (84.4%) had normal and benign MRI findings and were classified as BIRADS-1 and 2. Furthermore, 25 women (10.5%) were recommended MRI or US follow-up six months later and were classified as BIRADS-3. The remaining 12 women (5.1%) were recommended biopsy based on MRI findings and were classified as BIRADS-4. After the second look ultrasound, five women were recategorized as BIRADS-3, and ultrasound follow-up was recommended. The follow-up of these five women and 25 women with BIRADS-3 did not show any malignancy for two years. Finally, a core biopsy was performed for the remaining seven patients for whom biopsy was required according to the MRI findings. In the histopathology results, malignancy was not detected in any patient. The positive predictive value (PPV) for biopsy was 0%. However, there was only one risk lesion, an intraductal papilloma (Fig. 3 – 6 ). The follow-up mammography results of all women included in the study were evaluated after a 2-year follow-up, and no evidence of malignancy was found within two years. No significant differences could be found between patients undergoing a breast biopsy according to the MRI findings and patients without a biopsy regarding demographic features, including menopausal status, family history, and use of hormone replacement therapy, as shown in Table 1. Patients with a lower BMI (< 25) were more likely to have a mammogram with a higher density (ACR D: BMI; <25: 9.3% vs BMI; ≥ 25: 1.8%; p = 0.015). DISCUSSION This study showed no additional cancer detection through supplemental AP MRI screening for women with average risk and dense breasts. During a 2-year follow-up period, no evidence of malignancy was observed. Nevertheless, several studies have reported a significantly higher additional cancer detection rate (CDR), ranging from 11.8 to 27.4 per 1000 screenings with supplemental MRI screening ( 22 , 23 , 44 , 45 , 46 ). These studies featured different inclusion criteria, encompassing both high-risk and average-risk women and various breast density types, including C and D-type breasts and D-type breasts exclusively. However, a common finding across all these studies is the elevated additional CDR compared to mammography. Several factors may explain the unexpected result of our study. First, the sample size in our study was relatively small. Nonetheless, in a study by Weinstein et al. ( 45 ), which included 475 women, a remarkably high CDR of 27.4 per 1000 screenings was reported after DBT screening, known to detect more cancers than mammography. Similarly, Kuhl et al. ( 27 ) found a CDR of 18.2 per 1000 in 606 women supplementary to mammography screening. Both studies closely resemble our cohort of 238 women. This suggests that with our sample size, at least two cancers should have been detected, as according to the literature, 2.8 to 6.6 additional cancers per screening should be expected for such a cohort of 238 women. However, it's important to note the very limited number of participants in our study. Considering the acceptance rate of AP MRI screening among the invited women, stood at 38.5%, with 37.8% of them completing high-quality AP MRI screening. This relatively low number of study inclusions may have introduced a bias to our results. Second, the women in our study had undergone five rounds of mammography screening over ten years. It is well-established that after successive rounds of screening, interval cancers tend to decrease. The CDR among the women who underwent MRI was 16.5 per 1000 screenings in Bakker et al.’s study ( 46 ). The second screening round of their study showed a CDR of 5.8 per 1000 screening examinations compared with 16.5 per 1000 in the first round ( 47 ). So, Bakker et al’ results strongly support the decrease of CDR after successive screening rounds. However, in the ACRIN 6666 study ( 22 ), it was demonstrated that after three consecutive rounds of mammography screening supplemented with US screening, they could still detect 14.7 additional cancers per 1000 screenings with MRI. Conversely, we have not detected any cancer with supplementary MRI screening. Third, our interval cancer rate was notably lower (2.03 per 1000 screening) ( 42 ). In the Dense trial, the interval cancer rate was 5, subsequently decreasing to 0.8 per 1000 screenings after MRI screening ( 46 ). However, our interval cancer rate was notably lower than the Dense trial. This difference may have diminished the significant impact of the supplementary AP-MRI screening results. Despite high CDR, long scan acquisition, and interpretation time, high cost limits breast MRI for screening in all women-risk populations. Therefore, the 2007 American Cancer Society (ACS) has recommended additional breast MRI screening for women at high risk. This group includes women with genetics-based increased risk and their untested first-degree relatives, those with a calculated lifetime risk of 20% or greater, and those with a history of chest or mantle radiation therapy at a young age ( 24 ). A more personalized approach should be favored over offering MRI screening to every woman with risk. A recent study by Lamb LR et al. utilizing a mammography-based AI risk assessment tool demonstrated a higher CDR in women evaluated by this AI-based tool compared to traditional risk models ( 48 ). Furthermore, this study highlights that the risk assessment is contingent on the fibroglandular structure observed in mammography rather than the ACR density categories or conventional risk scores. Although many guides do not recommend MRI screening for average-risk women ( 49 – 51 ), EUSOBI has published a new recommendation that recommends supplemental full protocol MRI screening to women with extremely dense breasts from age 50–70 and at least every four years, preferably every 2 or 3 years in March 2022 ( 26 ). ACR guideline supports that MRI screening can be beneficial for dense breasts despite the accumulation of sufficient data ( 22 , 23 , 51 ). However, a study conducted by Geuzinge HA et al. ( 52 ) calibrated with the findings from the Dense trial ( 45 ), demonstrated the cost-effectiveness of MRI screening at 4-year intervals, with a cost of €15,620 per Quality-Adjusted Life Year (QALY). This assessment utilized a threshold of €22,000 per QALY gained. Consequently, a three or 2-year interval for MRI screening was deemed not cost-effective. Although our study did not specifically assess the cost-effectiveness of MRI screening, countries with limited resources need to be mindful of the limitations associated with MRI screening and carefully evaluate its cost-effectiveness. Our study represents a feasibility assessment to explore the potential integration of AP breast MRI into a screening program. Despite numerous studies in the literature demonstrating higher CDR ( 44 , 45 ), our findings did not align with these previous reports. While AP breast MRI holds promise as a screening modality, several operational considerations must be addressed to facilitate its adoption into clinical practice. For instance, it is widely accepted that reducing image acquisition and interpretation times can enhance availability and cost-effectiveness. However, the reality in real-life scenarios often diverges from these expectations, particularly within government hospital systems, where cost reduction may not be readily achievable. One of the challenges we encountered during the study was incorporating screening AP-MRI into a schedule already filled with diagnostic MRI appointments. This proved to be a daily operational challenge. Additionally, while image acquisition and interpretation times may be shorter, there remains a debate about the actual overall workflow efficiency. A study by Borthakur et al. ( 53 ) investigated various aspects of workflow, including imaging setup, patient preparation, and MRI room turnover, revealing that the flow rate for an abbreviated MRI examination was lower than anticipated. Therefore, radiologists and clinicians should be aware of these practical challenges when considering the implementation of AP breast MRI into clinical practice. The challenges in clinical practice extend beyond longer-than-expected total procedure times. For example, incorporating screening AP MRI into an appointment schedule filled with diagnostic MRI appointments posed practical difficulties. Furthermore, it has been observed that AP MRI can increase the rate of unnecessary biopsies, leading to increased costs. This represents one of the primary disadvantages of incorporating screening MRI. However, the EUSOBI guideline recommends screening for women with extremely dense breasts from age 50–70 and at least every four years, which seems to offer potential advantages, particularly considering the findings from the Dense Trial ( 46 ). Nevertheless, in contemplating the integration of AP MRI into a screening program, one must bear in mind the possible challenges given above. Our study has some limitations. First, the number of participants was low to make an optimal comparison with MRI and mammography. Second, the number of women who did not respond was very high, possibly due to being called up after five screening rounds. This study represents a real-life scenario involving the implementation of supplemental breast screening for women with dense breasts. The study revealed no additional cancer detection among the 238 women with dense breasts. However, this result came at the cost of a 15.5% recall rate, a 5% biopsy recommendation, and a 3% biopsy rate. Furthermore, the study encountered several challenges, including scheduling appointments within a busy MRI schedule and managing various aspects of workflow. It is crucial to consider these limitations when considering the implementation of MRI in large-scale screening programs. Meticulous criteria should be applied when selecting women for MRI screening to ensure optimal outcomes. CONCLUSION Although our study cohort was small, it highlights that supplemental AP MRI screening may not offer universal benefits for all women with dense breasts. The use of AP breast MRI could potentially lead to overdiagnosis and unnecessary biopsies, primarily due to false positive findings on MRI scans. Additionally, logistical constraints in arranging early appointments pose a significant challenge when considering the adoption of this technique as a supplementary screening tool in larger patient populations. The implementation of MRI screening should only be contemplated after a thorough analysis of the screening program and an assessment of available resources within the country. Declarations Acknowledgments : The authors thank the Bahçeşehir Breast Screening Facility, including, Nursen Has, Deniz Doğan Ozkan, Semra Yasar, and Ahu Ozdemir in particular, for providing the screening data used in this study. We are grateful to all Turkish women who participated in this prospective trial. Statement of Ethics All procedures performed in the present study involving human participants were by the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The authors declare that the subjects have given their written informed consent and that the Institute’s Ethical Committee of Marmara University has approved the study protocol. (Application No.: 2007/152, Date: 24.01.2007/01). Conflict of Interest All authors declare that there are no potential conflicts of interest concerning the research, authorship, or publication of this article. Funding Sources This project is supported by Roche Pharmaceutical Company. Authors’ contributions: The study was designed by EA and NC. IK, NC, and EA performed the initial search, literature organization, analyses, and manuscript writing. 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Expert Panel on Breast Imaging, Mainiero MB, Moy L, et al. ACR Appropriateness Criteria: Breast cancer screening. J Am Coll Radiol. 2017;14:S383–90. Geuzinge HA, Bakker MF, Heijnsdijk EAM, et al. DENSE trial study group. Cost-Effectiveness of Magnetic Resonance Imaging Screening for Women with Extremely Dense Breast Tissue. J Natl Cancer Inst. 2021;2:113:1476–83. Borthakur A, Weinstein SP, Schnall MD, Conant EF. Comparison of Study Activity Times for Full versus Fast MRI for Breast Cancer Screening. J Am Coll Radiol. 2019;16:1046–51. Tables Table 1 is available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Tables.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4717166","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":325993801,"identity":"a7c62a82-f166-4a08-8c4c-ae5b22b6677e","order_by":0,"name":"Inci Kizildag Yirgin","email":"data:image/png;base64,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","orcid":"","institution":"Istanbul University","correspondingAuthor":true,"prefix":"","firstName":"Inci","middleName":"Kizildag","lastName":"Yirgin","suffix":""},{"id":325993802,"identity":"64ed09fa-fbef-4603-a61c-4fe6e60567f7","order_by":1,"name":"Neslihan Cabioglu","email":"","orcid":"","institution":"Istanbul University","correspondingAuthor":false,"prefix":"","firstName":"Neslihan","middleName":"","lastName":"Cabioglu","suffix":""},{"id":325993803,"identity":"f456980d-5a96-4264-a71a-cb2d98a150fb","order_by":2,"name":"Memduh Dursun","email":"","orcid":"","institution":"Istanbul University","correspondingAuthor":false,"prefix":"","firstName":"Memduh","middleName":"","lastName":"Dursun","suffix":""},{"id":325993805,"identity":"0da5a099-65d8-49b4-b11c-be2a5e409511","order_by":3,"name":"Omur Can","email":"","orcid":"","institution":"Bahçeşehir Breast Cancer Screening Center","correspondingAuthor":false,"prefix":"","firstName":"Omur","middleName":"","lastName":"Can","suffix":""},{"id":325993808,"identity":"958b0405-2a40-48e0-aa8d-e09e8a229751","order_by":4,"name":"Aziz Sener","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Aziz","middleName":"","lastName":"Sener","suffix":""},{"id":325993810,"identity":"3768a94e-9a25-45d5-b784-6dec0ca5d4cd","order_by":5,"name":"Gulcin Vatandas","email":"","orcid":"","institution":"Bahçeşehir Breast Cancer Screening Center","correspondingAuthor":false,"prefix":"","firstName":"Gulcin","middleName":"","lastName":"Vatandas","suffix":""},{"id":325993811,"identity":"797258f9-63ae-46fc-8778-38cdff6b5810","order_by":6,"name":"Gonul Aykuter","email":"","orcid":"","institution":"Bahçeşehir Breast Cancer Screening Center","correspondingAuthor":false,"prefix":"","firstName":"Gonul","middleName":"","lastName":"Aykuter","suffix":""},{"id":325993812,"identity":"790eba09-1adc-4058-b5c5-1467c4d77286","order_by":7,"name":"Ravza Yilmaz","email":"","orcid":"","institution":"Istanbul University","correspondingAuthor":false,"prefix":"","firstName":"Ravza","middleName":"","lastName":"Yilmaz","suffix":""},{"id":325993813,"identity":"89bbbdd2-17b7-41dc-9d8f-cb73148187af","order_by":8,"name":"Ayse Nilufer Ozaydin","email":"","orcid":"","institution":"Marmara University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Ayse","middleName":"Nilufer","lastName":"Ozaydin","suffix":""},{"id":325993814,"identity":"a0c27c5f-2b42-4263-8fea-ab743091960c","order_by":9,"name":"Sibel Ozkan Gurdal","email":"","orcid":"","institution":"Namik Kemal University","correspondingAuthor":false,"prefix":"","firstName":"Sibel","middleName":"Ozkan","lastName":"Gurdal","suffix":""},{"id":325993815,"identity":"33210218-80a2-4129-82ba-85e60c1e9099","order_by":10,"name":"Beyza Ozcinar","email":"","orcid":"","institution":"Istanbul University","correspondingAuthor":false,"prefix":"","firstName":"Beyza","middleName":"","lastName":"Ozcinar","suffix":""},{"id":325993816,"identity":"17f98f6a-4da5-4053-8962-5608c4fa7708","order_by":11,"name":"Nuran Akyurt","email":"","orcid":"","institution":"Techniques Marmara University Istanbul","correspondingAuthor":false,"prefix":"","firstName":"Nuran","middleName":"","lastName":"Akyurt","suffix":""},{"id":325993817,"identity":"3c4f1ad9-cfbf-41c1-a50a-aba3d01e25d7","order_by":12,"name":"Vahit Ozmen","email":"","orcid":"","institution":"Istanbul University","correspondingAuthor":false,"prefix":"","firstName":"Vahit","middleName":"","lastName":"Ozmen","suffix":""},{"id":325993819,"identity":"bb472240-7f81-40ae-a8bf-3adfe98c6da8","order_by":13,"name":"Arda Kayhan","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Arda","middleName":"","lastName":"Kayhan","suffix":""},{"id":325993821,"identity":"53151c5d-d27c-4b0b-897b-58ab0da1283d","order_by":14,"name":"Erkin Aribal","email":"","orcid":"","institution":"Acibadem M.A.A University school of medicine","correspondingAuthor":false,"prefix":"","firstName":"Erkin","middleName":"","lastName":"Aribal","suffix":""}],"badges":[],"createdAt":"2024-07-10 09:59:32","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4717166/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4717166/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":62187484,"identity":"b308b113-5aaa-42bd-91a2-a65c34521ef9","added_by":"auto","created_at":"2024-08-10 12:11:47","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":43869,"visible":true,"origin":"","legend":"\u003cp\u003eStudy Flow.\u003c/p\u003e","description":"","filename":"Figure1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4717166/v1/3904ee755654f2d152e8f77c.jpeg"},{"id":62189048,"identity":"e64d6e0a-f543-4504-9c54-7791772691cb","added_by":"auto","created_at":"2024-08-10 12:19:47","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":49267,"visible":true,"origin":"","legend":"\u003cp\u003eComposition abbreviated protocol. Loc, localizer images; FS, fat-saturated images; STIR, short-tau inversion recovery; post, dynamic postcontrast images; sub, T1 fat-saturated postcontrast subtraction images.\u003c/p\u003e","description":"","filename":"Figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4717166/v1/b349a014fa4980be0be50d29.jpg"},{"id":62187490,"identity":"6aea16aa-4503-454b-999c-66646e7b13e5","added_by":"auto","created_at":"2024-08-10 12:11:47","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":68369,"visible":true,"origin":"","legend":"\u003cp\u003e52-year-old postmenopausal women. \u003cstrong\u003ea) and b)\u003c/strong\u003e CC and MLO mammograms show heterogeneous dense breast parenchyma with no abnormal findings. Pre-contrast non-fat-sat T1A images\u003cstrong\u003e(c), \u003c/strong\u003epre-contrast fat-sat T1A images\u003cstrong\u003e(e),\u003c/strong\u003e post-contrast fat-sat T1A images\u003cstrong\u003e(d),\u003c/strong\u003e MIP images \u003cstrong\u003e(f)\u003c/strong\u003eshow no parenchymal contrast enhancement or any lesion.\u003c/p\u003e","description":"","filename":"Figure3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4717166/v1/e2d98cd8042ec5b3edc10eaa.jpg"},{"id":62187489,"identity":"66eec848-5fbe-4671-b06e-cfbfa1d72408","added_by":"auto","created_at":"2024-08-10 12:11:47","extension":"jpg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":46023,"visible":true,"origin":"","legend":"\u003cp\u003e45-year-old postmenopausal women. \u003cstrong\u003ea) and b)\u003c/strong\u003e CC and MLO mammograms show extremely dense breast parenchyma with benign coarse calcifications in both breasts (BIRADS-2)\u003c/p\u003e","description":"","filename":"Figure4.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4717166/v1/b1611af212ee3906a9f837e2.jpg"},{"id":62190447,"identity":"0db5fc1f-fc9b-4b3b-976a-f9a97dd843a6","added_by":"auto","created_at":"2024-08-10 12:27:47","extension":"jpg","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":55033,"visible":true,"origin":"","legend":"\u003cp\u003eAbbreviated MR images of the previous figure. Pre-contrast non-fat-sat T1A images \u003cstrong\u003e(a), \u003c/strong\u003epost-contrast fat-sat T1A images \u003cstrong\u003e(b),\u003c/strong\u003e T2W-fat sat \u003cstrong\u003e(c), and \u003c/strong\u003esubtracted image \u003cstrong\u003e(d)\u003c/strong\u003eshow a contrast-enhanced solid lesion in the lower outer quadrant of the right breast (white arrows), (BIRADS-4). Biopsy-pathology results reported apocrine metaplasia, ductal ectasia, and stromal fibrosis.\u003c/p\u003e","description":"","filename":"Figure5.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4717166/v1/da5246afcb99dd298c3dfe83.jpg"},{"id":62189046,"identity":"1ab24afa-fdf0-484b-a073-189513c94cdb","added_by":"auto","created_at":"2024-08-10 12:19:47","extension":"jpg","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":29563,"visible":true,"origin":"","legend":"\u003cp\u003e46-year-old postmenopausal women. T2W-fat sat \u003cstrong\u003e(a), \u003c/strong\u003esubtracted image \u003cstrong\u003e(b)\u003c/strong\u003e shows a contrast-enhanced lesion in the upper outer quadrant of the left breast (white arrows), (BIRADS-4). Biopsy-pathology results reported fibroadenomatous changes.\u003c/p\u003e","description":"","filename":"Figure6.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4717166/v1/32c09f00637556f857ce2769.jpg"},{"id":82246250,"identity":"75c0c5eb-af36-4cf0-872c-1f88145207b8","added_by":"auto","created_at":"2025-05-08 09:08:51","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":851862,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4717166/v1/762d8a97-2ede-4be5-bd26-4c8ac7a83c00.pdf"},{"id":62187487,"identity":"acc78591-4a15-4005-9896-21fd8ef2ec9b","added_by":"auto","created_at":"2024-08-10 12:11:47","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":19338,"visible":true,"origin":"","legend":"","description":"","filename":"Tables.docx","url":"https://assets-eu.researchsquare.com/files/rs-4717166/v1/231168925ace23e9688e2cc7.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eAbbreviated MRI Screening in Turkish Women Aged 40-69 With Dense Breasts: A Prospective Feasibility Study\u003c/p\u003e","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eBreast cancer is the most common cancer type and the second cause of cancer-related mortality in women worldwide, according to the 2020 global cancer statistics (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). It is known that the survival time and quality of life increase with the early diagnosis of breast cancer (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). Randomized controlled studies have shown a reduction in mortality of up to 30% when breast cancer screening is performed with mammography (MG), and it is the standard screening method (\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). The major limitation of MG is the 2-dimensional, anatomic imaging technique that could mask breast cancer in dense breasts. Studies have shown that, within groups of the same age, there are two to six times higher risk of breast cancer in dense breasts than in non-dense breasts (\u003cspan additionalcitationids=\"CR7\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Therefore, cancer screening in women with dense breasts needs further attention.\u003c/p\u003e \u003cp\u003eWhole-breast ultrasound (WBUS) is one of the supplemental screening methods in women with dense breasts. Studies have shown a moderate cancer detection rate (CDR) averaging 2.0-4.7 per 1,000 screened cases (\u003cspan additionalcitationids=\"CR10 CR11 CR12\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). While the method moderately increases its sensitivity, it is associated with high false-positive rates and short-term follow-up (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eDigital breast tomosynthesis (DBT) is a relatively new technique and has demonstrated better sensitivity and specificity than MG in women with dense breasts. Additionally, a decrease in false-positive rates and an increase in cancer detection rate averaging 1.6 additional cancers per 1000 women screened have been reported (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eMagnetic resonance imaging (MRI) has been accepted as the most sensitive imaging tool for detecting breast cancer (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). The advantages, such as soft tissue resolution and dynamic and multiplanar imaging, can lead to smaller cancers than 5 mm (\u003cspan additionalcitationids=\"CR20\" citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). The American College of Radiology has broadened its recommendations to encompass women with a personal history of breast cancer, those with dense breast tissue, and individuals under 50 who have received a cancer diagnosis (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). There was no authority recommending that women with average risk and dense breast structure in the normal population be screened with complete breast MRI until March 2022. European Society of Breast Imaging (EUSOBI) has recently published a new recommendation that suggests supplemental MRI screening for women with extremely dense breasts from age 50\u0026ndash;70 at least every four years, preferably every 2 or 3 years, in March 2022 (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eMany studies have investigated new options to decrease the high costs and scan time of complete diagnostic MRI to make it feasible. Kuhl et al. introduced the abbreviated protocol (AP) for breast MRI, demonstrating equivalent diagnostic accuracy to complete breast MRI in women with dense breasts (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). Several studies have been published showing the high diagnostic accuracy of AP breast MRI with faster performance and lower cost (\u003cspan additionalcitationids=\"CR29 CR30 CR31 CR32 CR33 CR34 CR35\" citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e). AP breast MRI protocols described in the literature are broadly consistent, with minor variations primarily seen in the T2 and diffusion-weighted series (\u003cspan additionalcitationids=\"CR38\" citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e). Generally, the AP consists of a T1W precontrast, a first post-contrast T1W sequence, a subtracted image, and maximum intensity projection (MIP). Unlike benign lesions, the technique is based on the early enhancement of breast cancers. During the initial phases of dynamic images, background parenchymal enhancement is lower, which can minimize the masking effect in dense breasts.\u003c/p\u003e \u003cp\u003eAlthough there is a national screening program in Turkey, mammographic screenings are mostly opportunistic (\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e, \u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e). Bahcesehir Breast Cancer Screening Project (BMSCP) is a pilot study and an organized population-based biennial screening program that has been carried out on women aged 40\u0026ndash;69 living in the county Bahcesehir of Istanbul between 2009 and 2019 (\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e). This screening program investigated the feasibility of a population-based organized breast cancer screening program in Turkey as a middle-income country. In this study, we aimed to investigate the feasibility of AP breast MRI screening in women with dense breasts in the BMSCP.\u003c/p\u003e"},{"header":"MATERIALS AND METHODS","content":"\u003cp\u003eThe study was approved by the Institutional Review Board of Marmara University (Application No.: 2007/152, Date: 24.01.2007/01). Informed consent was obtained from those eligible women invited to the study who accepted to participate.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003ePopulation\u003c/h2\u003e \u003cp\u003eDigital mammograms were collected from BMSP, which is an organized, population-based, 10-year (2009\u0026ndash;2019) mammography screening program in Turkey. During the 10 years, biennially, screening was carried out in 8758 women between ages 40 and 69 living in the region who were registered to the Bah\u0026ccedil;eşehir Breast Cancer Screening Center between January 2009 and January 2019. A total of 22621 bilateral mammography was recorded in the archival system. In the last year of the screening program (between January 2018 and January 2019), mammography was performed on 3299 women. The number of women with heterogeneous dense and extremely dense breast tissue (type C and D) was 1285. Additional screening AP breast MRI was offered to women randomized in a ratio of 2 to 1. As a result, 629 women were invited to the study for AP MRI. Of those, 387 women did not undergo additional MRI screening for the following reasons: 231 didn\u0026rsquo;t respond, 145 declined to participate, 9 had claustrophobia, and 2 had contrast agent allergy (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Finally, 242 agreed to an MRI screening, but images in 4 MR examinations were inadequate to evaluate following a quality assessment. Finally, 238 patients who have heterogeneous dense and extremely dense breast tissue (type C and D) according to the American College of Radiology (ACR) criteria and negative physical examination with negative mammography results were included in the study.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e Pathology results obtained with biopsies performed after abbreviated MRI scans and normal screening mammography results within two years were accepted as the reference standard.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eMammograms\u003c/h2\u003e \u003cp\u003eDigital mammography images were obtained using a full-field digital mammographic device (Selenia, Hologic) from the screening center. Two projections, mediolateral oblique and craniocaudal, were obtained for each woman. Two breast radiologists with more than five years of experience independently read mammograms in the screening center. In case of inconsistency between the readers, a third radiologist with more than 20 years of experience interpreted the findings for the final decision. Mammographic findings were evaluated under the guidance of the 4th edition of Breast Imaging-Reporting and Data System (BIRADS) of the ACR because BMSP had already started before the last updated 5th version of BIRADS. MRI findings were evaluated under the guidance of the 5th edition of Breast Imaging-Reporting and Data System of the BIRADS (\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIf a suspicious abnormality or highly suggestive of malignancy (BI-RADS 4 or 5 cases) was detected in the imaging in the final report, the radiologists decided on whether to perform a core needle aspiration biopsy (CNB) guided by ultrasonography (14\u0026ndash;16 gauge), or a vacuum assisted large core (11 gauge) stereotactic (VALCS) biopsy. Screening is biennial, giving a window of 24 months for an interval cancer to become symptomatic after a negative screening mammography. The prospectively collected outcome data was entered into a computer database as suggested by ACR. Data on pathologic features, any administered therapies, follow-up, and survival outcomes were gathered from our patient and pathology databases.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eMagnetic Resonance Imaging\u003c/h2\u003e \u003cp\u003eAP MRI scans were performed in 2 different radiology centers. All MRI scans were applied using a 1.5 T MR scanner (Symphony, Siemens Medical Solutions), and a dedicated channel phased-array breast coil was used. Before dynamic sequences, an intravenous bolus injection of 0.2 ml/kg (standard dose) gadopentetate dimeglumine (Magnevist; Bayer Schering Pharma, Berlin, Germany) was administered, followed by 20 ml of saline. Each patient underwent AP breast MRI in 1\u0026ndash;12 weeks after screening mammography. The AP consists of the dynamic series' first and second post-contrast phases and axial T1W and axial T2W-fat sat (TRIM) sequences (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Scan acquisition time was 7\u0026ndash;10 minutes. On a pixel-by-pixel basis, unenhanced images were subtracted from contrast-enhanced images, producing a single subtracted post-contrast subtraction sequence. Two dedicated breast radiologists performed image quality assessment, who evaluated the images for fat saturation, artifact severity, and quality of normal anatomic structures as described before (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e). When MRI images were evaluated, normal and benign findings were concluded as BIRADS-1 and 2, the cases MRI or US follow-up was recommended after six months concluded as BIRADS-3 and the patients for whom biopsy was recommended concluded as BIRADS-4.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eStatistical software SPSS 25 was used for analyses (Statistical Package for Social Sciences; SPSS, IBM Corp., Armonk, NY, USA) 17.0 (SPSS Inc., Chicago, IL, USA). Categorical variables were evaluated by the Pearson Chi-square test. Mann-Whitney U test was used to determine the differences between continuous variables. A p-value equal to or less than 0.05 was statistically significant.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cp\u003eA total of 238 women with type C and D breasts were included in the study. The median age was 44 (min, 40\u0026ndash;62), and the mean was 45.5+/- 0.34 years. The physical examination findings of all these women were evaluated as normal. Of those, 14 women were in the extremely dense (ACR type D) group, and 224 were in the heterogeneous dense (ACR type C) group. The screening mammography results were as follows: 88 women had BIRADS-1, and 150 women had BIRADS-2 imaging findings. All patients had an MRI after MMG in a month to 6 months due to the restrictions to organize the appointment in busy diagnostic MRI schedules.\u003c/p\u003e \u003cp\u003eOf the MRI scan results, 201 women (84.4%) had normal and benign MRI findings and were classified as BIRADS-1 and 2. Furthermore, 25 women (10.5%) were recommended MRI or US follow-up six months later and were classified as BIRADS-3. The remaining 12 women (5.1%) were recommended biopsy based on MRI findings and were classified as BIRADS-4. After the second look ultrasound, five women were recategorized as BIRADS-3, and ultrasound follow-up was recommended. The follow-up of these five women and 25 women with BIRADS-3 did not show any malignancy for two years.\u003c/p\u003e \u003cp\u003eFinally, a core biopsy was performed for the remaining seven patients for whom biopsy was required according to the MRI findings. In the histopathology results, malignancy was not detected in any patient. The positive predictive value (PPV) for biopsy was 0%. However, there was only one risk lesion, an intraductal papilloma (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe follow-up mammography results of all women included in the study were evaluated after a 2-year follow-up, and no evidence of malignancy was found within two years.\u003c/p\u003e \u003cp\u003eNo significant differences could be found between patients undergoing a breast biopsy according to the MRI findings and patients without a biopsy regarding demographic features, including menopausal status, family history, and use of hormone replacement therapy, as shown in Table\u0026nbsp;1. Patients with a lower BMI (\u0026lt;\u0026thinsp;25) were more likely to have a mammogram with a higher density (ACR D: BMI; \u0026lt;25: 9.3% vs BMI; \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026ge;\u003c/span\u003e25: 1.8%; p\u0026thinsp;=\u0026thinsp;0.015).\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis study showed no additional cancer detection through supplemental AP MRI screening for women with average risk and dense breasts. During a 2-year follow-up period, no evidence of malignancy was observed. Nevertheless, several studies have reported a significantly higher additional cancer detection rate (CDR), ranging from 11.8 to 27.4 per 1000 screenings with supplemental MRI screening (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e, \u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e, \u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e). These studies featured different inclusion criteria, encompassing both high-risk and average-risk women and various breast density types, including C and D-type breasts and D-type breasts exclusively. However, a common finding across all these studies is the elevated additional CDR compared to mammography.\u003c/p\u003e \u003cp\u003eSeveral factors may explain the unexpected result of our study. First, the sample size in our study was relatively small. Nonetheless, in a study by Weinstein et al. (\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e), which included 475 women, a remarkably high CDR of 27.4 per 1000 screenings was reported after DBT screening, known to detect more cancers than mammography. Similarly, Kuhl et al. (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e) found a CDR of 18.2 per 1000 in 606 women supplementary to mammography screening. Both studies closely resemble our cohort of 238 women. This suggests that with our sample size, at least two cancers should have been detected, as according to the literature, 2.8 to 6.6 additional cancers per screening should be expected for such a cohort of 238 women. However, it's important to note the very limited number of participants in our study. Considering the acceptance rate of AP MRI screening among the invited women, stood at 38.5%, with 37.8% of them completing high-quality AP MRI screening. This relatively low number of study inclusions may have introduced a bias to our results.\u003c/p\u003e \u003cp\u003eSecond, the women in our study had undergone five rounds of mammography screening over ten years. It is well-established that after successive rounds of screening, interval cancers tend to decrease. The CDR among the women who underwent MRI was 16.5 per 1000 screenings in Bakker et al.\u0026rsquo;s study (\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e). The second screening round of their study showed a CDR of 5.8 per 1000 screening examinations compared with 16.5 per 1000 in the first round (\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e). So, Bakker et al\u0026rsquo; results strongly support the decrease of CDR after successive screening rounds. However, in the ACRIN 6666 study (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e), it was demonstrated that after three consecutive rounds of mammography screening supplemented with US screening, they could still detect 14.7 additional cancers per 1000 screenings with MRI. Conversely, we have not detected any cancer with supplementary MRI screening.\u003c/p\u003e \u003cp\u003eThird, our interval cancer rate was notably lower (2.03 per 1000 screening) (\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e). In the Dense trial, the interval cancer rate was 5, subsequently decreasing to 0.8 per 1000 screenings after MRI screening (\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e). However, our interval cancer rate was notably lower than the Dense trial. This difference may have diminished the significant impact of the supplementary AP-MRI screening results.\u003c/p\u003e \u003cp\u003eDespite high CDR, long scan acquisition, and interpretation time, high cost limits breast MRI for screening in all women-risk populations. Therefore, the 2007 American Cancer Society (ACS) has recommended additional breast MRI screening for women at high risk. This group includes women with genetics-based increased risk and their untested first-degree relatives, those with a calculated lifetime risk of 20% or greater, and those with a history of chest or mantle radiation therapy at a young age (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). A more personalized approach should be favored over offering MRI screening to every woman with risk. A recent study by Lamb LR et al. utilizing a mammography-based AI risk assessment tool demonstrated a higher CDR in women evaluated by this AI-based tool compared to traditional risk models (\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e). Furthermore, this study highlights that the risk assessment is contingent on the fibroglandular structure observed in mammography rather than the ACR density categories or conventional risk scores. Although many guides do not recommend MRI screening for average-risk women (\u003cspan additionalcitationids=\"CR50\" citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e), EUSOBI has published a new recommendation that recommends supplemental full protocol MRI screening to women with extremely dense breasts from age 50\u0026ndash;70 and at least every four years, preferably every 2 or 3 years in March 2022 (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). ACR guideline supports that MRI screening can be beneficial for dense breasts despite the accumulation of sufficient data (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e). However, a study conducted by Geuzinge HA et al. (\u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e52\u003c/span\u003e) calibrated with the findings from the Dense trial (\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e), demonstrated the cost-effectiveness of MRI screening at 4-year intervals, with a cost of \u0026euro;15,620 per Quality-Adjusted Life Year (QALY). This assessment utilized a threshold of \u0026euro;22,000 per QALY gained. Consequently, a three or 2-year interval for MRI screening was deemed not cost-effective. Although our study did not specifically assess the cost-effectiveness of MRI screening, countries with limited resources need to be mindful of the limitations associated with MRI screening and carefully evaluate its cost-effectiveness.\u003c/p\u003e \u003cp\u003eOur study represents a feasibility assessment to explore the potential integration of AP breast MRI into a screening program. Despite numerous studies in the literature demonstrating higher CDR (\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e, \u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e), our findings did not align with these previous reports. While AP breast MRI holds promise as a screening modality, several operational considerations must be addressed to facilitate its adoption into clinical practice. For instance, it is widely accepted that reducing image acquisition and interpretation times can enhance availability and cost-effectiveness. However, the reality in real-life scenarios often diverges from these expectations, particularly within government hospital systems, where cost reduction may not be readily achievable. One of the challenges we encountered during the study was incorporating screening AP-MRI into a schedule already filled with diagnostic MRI appointments. This proved to be a daily operational challenge. Additionally, while image acquisition and interpretation times may be shorter, there remains a debate about the actual overall workflow efficiency.\u003c/p\u003e \u003cp\u003eA study by Borthakur et al. (\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e) investigated various aspects of workflow, including imaging setup, patient preparation, and MRI room turnover, revealing that the flow rate for an abbreviated MRI examination was lower than anticipated. Therefore, radiologists and clinicians should be aware of these practical challenges when considering the implementation of AP breast MRI into clinical practice. The challenges in clinical practice extend beyond longer-than-expected total procedure times. For example, incorporating screening AP MRI into an appointment schedule filled with diagnostic MRI appointments posed practical difficulties. Furthermore, it has been observed that AP MRI can increase the rate of unnecessary biopsies, leading to increased costs. This represents one of the primary disadvantages of incorporating screening MRI. However, the EUSOBI guideline recommends screening for women with extremely dense breasts from age 50\u0026ndash;70 and at least every four years, which seems to offer potential advantages, particularly considering the findings from the Dense Trial (\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e). Nevertheless, in contemplating the integration of AP MRI into a screening program, one must bear in mind the possible challenges given above.\u003c/p\u003e \u003cp\u003eOur study has some limitations. First, the number of participants was low to make an optimal comparison with MRI and mammography. Second, the number of women who did not respond was very high, possibly due to being called up after five screening rounds.\u003c/p\u003e \u003cp\u003eThis study represents a real-life scenario involving the implementation of supplemental breast screening for women with dense breasts. The study revealed no additional cancer detection among the 238 women with dense breasts. However, this result came at the cost of a 15.5% recall rate, a 5% biopsy recommendation, and a 3% biopsy rate. Furthermore, the study encountered several challenges, including scheduling appointments within a busy MRI schedule and managing various aspects of workflow. It is crucial to consider these limitations when considering the implementation of MRI in large-scale screening programs. Meticulous criteria should be applied when selecting women for MRI screening to ensure optimal outcomes.\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eAlthough our study cohort was small, it highlights that supplemental AP MRI screening may not offer universal benefits for all women with dense breasts. The use of AP breast MRI could potentially lead to overdiagnosis and unnecessary biopsies, primarily due to false positive findings on MRI scans. Additionally, logistical constraints in arranging early appointments pose a significant challenge when considering the adoption of this technique as a supplementary screening tool in larger patient populations. The implementation of MRI screening should only be contemplated after a thorough analysis of the screening program and an assessment of available resources within the country.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e: The authors thank\u0026nbsp;the Bah\u0026ccedil;eşehir Breast Screening Facility, including,\u0026nbsp;Nursen Has, Deniz Doğan Ozkan, Semra Yasar, and Ahu Ozdemir in particular, for providing the screening data used in this study. We are grateful to all Turkish women who participated in this prospective trial.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatement of Ethics\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll procedures performed in the present study involving human participants were by the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The authors declare that the subjects have given their written informed consent and that the Institute\u0026rsquo;s Ethical Committee of Marmara University has approved the study protocol.\u0026nbsp;(Application No.: 2007/152, Date: 24.01.2007/01).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of Interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors declare that there are no potential conflicts of interest concerning the research, authorship, or publication of this article.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding Sources\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis project is supported by Roche Pharmaceutical Company.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was designed by EA and NC. IK, NC, and EA performed the initial search, literature organization, analyses, and manuscript writing. EA, MD, IK, OC, NC, and RY provided data acquisition.\u0026nbsp;AS, NO, SOG, BO, VO, and AK made critical comments and typesetting corrections on the final version. All authors have read and revised the manuscript critically.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003e\u003cspan\u003eData source. Globocan 2020 Graph production: Global Cancer Observatory (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://gco.iarc.fr\u003c/span\u003e\u003c/span\u003e).\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eGarne JP, Aspegren K, Balldin G, Ranstam J. Increasing incidence of and declining mortality from breast carcinoma. Cancer. 1997;79:6974.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eTabar L, Vitak B, Chen TH-H, et al. Swedish two-county trial: Impact of mammographic screening on breast cancer mortality during 3 decades. 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Eur J Breast Health. 2019;1:1\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eScoggins ME, Arun BK, Candelaria RP, et al. Should abbreviated breast MRI be compliant with the American College of Radiology requirements for MRI accreditation? Magn Reson Imaging. 2020;72:87\u0026ndash;94.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eFidaner C, Eser SY, Parkin M. Incidence in Izmir in 1993\u0026ndash;1994: First results from Izmir Cancer Registry. Eur J Cancer. 2001;37:83\u0026ndash;92.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eOzmen V. Breast Cancer in Turkey: Clinical and Histopathological Characteristics (Analysis of 13.240 Patients). J Breast Health. 2014;10:98\u0026ndash;105.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eOzkan Gurdal S, Ozaydin AN, Aribal E, et al. Bahcesehir long-term population-based screening compared to National Breast Cancer Registry Data: effectiveness of screening in an emerging country. Diagn Interv Radiol. 2021;27:157\u0026ndash;63.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eD\u0026rsquo;Orsi CJ, Sickles EA, Mendelson EB, et al. ACR BI-RADS \u0026reg; Atlas, Breast Imaging Reporting and Data System. Reston, VA: American College of Radiology; 2013.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eComstock CE, Gatsonis C, Newstead, et al. Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women with Dense Breasts Undergoing Screening. JAMA. 2020;323:746\u0026ndash;56.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eWeinstein SP, Korhonen K, Cirelli C. at al. Abbreviated Breast Magnetic Resonance Imaging for Supplemental Screening of Women with Dense Breasts and Average Risk. Journal of clinical oncology: official journal of the American Society of Clinical Oncology. 2020; \u003cem\u003e38\u003c/em\u003e: 3874\u0026ndash;3882.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eBakker MF, de Lange SV, Pijnappel, et al. DENSE Trial Study Group. Supplemental MRI Screening for Women with Extremely Dense Breast Tissue. N Engl J Med. 2019;381:2091\u0026ndash;102.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eVeenhuizen SGA, de Lange SV, Bakker MF, et al. DENSE Trial Study Group.Supplemental Breast MRI for Women with Extremely Dense Breasts: Results of the Second Screening Round of the DENSE Trial. Radiology. 2021;299:278\u0026ndash;86.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eLamb LR, Mercaldo SF, Ghaderi K, Carney A, Lehman CD. Comparison of the Diagnostic Accuracy of Mammogram-based Deep Learning and Traditional Breast Cancer Risk Models in Patients Who Underwent Supplemental Screening with MRI. Radiology. 2023;308:e223077.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eAmerican Cancer Society: American Cancer Society Releases New Breast Cancer Guideline. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.cancer.org/latest-news/american-cancer-societyreleases-new-breast-cancer-guidelines.html\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eNational Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Breast cancer Screening and Diagnosis. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eExpert Panel on Breast Imaging, Mainiero MB, Moy L, et al. ACR Appropriateness Criteria: Breast cancer screening. 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J Am Coll Radiol. 2019;16:1046\u0026ndash;51.\u003c/span\u003e\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1 is available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Breast, Neoplasms, Radiology, Breast density, Mammography","lastPublishedDoi":"10.21203/rs.3.rs-4717166/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4717166/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eSurvival time and quality of life increase with the early diagnosis of breast cancer. We aim to investigate the feasibility of abbreviated protocol (AP) breast magnetic resonance imaging (MRI) screening in women with dense breasts in a screening program in a middle-income country.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThe study included 649 women selected randomly from 1285 women with type C and D breasts in a screening program, of which 238 underwent an abbreviated breast MRI screening (AP-MRI). The AP-MRI consisted of dynamic series during the first and second post-contrast phases, in addition to axial T1W and axial T2W-fat sat (TRIM) sequences. The reference standard for the study was based on pathology results obtained from biopsies and normal screening mammography results within two years.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eMRI scans of 201 women (84.4%) displayed normal or benign findings (BIRADS-1 and 2). An additional 25 women (10.5%) were recommended for MRI or ultrasound (USG) follow-up (BI-RADS-3) and did not show any progression in the two-year follow-up. The remaining 12 women (5%) were recommended a biopsy (BIRADS-4), of which five were reclassified as BIRADS-3 after a second-look ultrasound. Subsequently, a biopsy of the remaining seven patients. did not reveal any malignancies. They all had a negative two-year follow-up. The main challenges encountered were scheduling AP-MRI screening and compliance of women.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThis study highlights that supplemental AP-MRI screening may not offer universal benefits for all women with dense breasts. The use of AP breast MRI could potentially lead to overdiagnosis and unnecessary biopsies, primarily due to false positive findings on MRI scans.\u003c/p\u003e","manuscriptTitle":"Abbreviated MRI Screening in Turkish Women Aged 40-69 With Dense Breasts: A Prospective Feasibility Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-08-10 12:11:42","doi":"10.21203/rs.3.rs-4717166/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"fd9a6ca9-e9da-4afd-8503-c90eff3009a2","owner":[],"postedDate":"August 10th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-05-08T09:08:15+00:00","versionOfRecord":[],"versionCreatedAt":"2024-08-10 12:11:42","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4717166","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4717166","identity":"rs-4717166","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}