A prospective observational role of magnetic resonance imaging and magnetic resonance spectroscopy in evaluation of choline levels in gall bladder carcinoma in tertiary care hospital in central India

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Parihar" }, { "@type": "Person", "name": "Sakshi Dudhe" } ], "publisher": { "@type": "Organization", "name": "F1000Research", "logo": { "@type": "ImageObject", "url": "https://f1000research.com/img/AMP/F1000Research_image.png", "height": 480, "width": 60 } }, "image": { "@type": "ImageObject", "url": "https://f1000research.com/img/AMP/F1000Research_image.png", "height": 1200, "width": 150 }, "description": " Background Gall bladder carcinoma (GBC) is a challenging malignancy characterized by late-stage diagnosis and poor prognosis. Early detection and accurate staging are crucial for improving patient outcomes. Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) offer non-invasive imaging modalities that may aid in the evaluation of GBC. Choline, a metabolite detected by MRS, has been implicated in tumor growth and may serve as a potential biomarker for GBC. This study aims to investigate the role of MRI and MRS in evaluating choline levels as biomarkers for GBC. Method A prospective observational study will be conducted involving patients with suspected or confirmed GBC referred to the Department of Radiology, AVBRH, Sawangi. Patients meeting inclusion criteria will undergo MRI scans and MRS examinations to assess tumor characteristics and choline levels. Data collected will include MRI images, MRS spectra, histopathological results, and clinical outcomes. Statistical analysis will be performed to examine correlations between MRI findings, choline levels, and histopathological characteristics. Expected Outcome It is anticipated that MRI and MRS will demonstrate utility in evaluating choline levels as imaging biomarkers for GBC. Correlations between choline levels, tumor characteristics, and clinical outcomes are expected to provide valuable insights into the role of choline in GBC pathogenesis and prognosis. If successful, MRI and MRS could serve as non-invasive tools for early detection, staging, and treatment response monitoring in GBC, ultimately leading to improved patient outcomes and management strategies. " } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://f1000research.com/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://f1000research.com/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://f1000research.com/articles/13-541", "name": "A prospective observational role of magnetic resonance imaging and..." } } ] } Home Browse A prospective observational role of magnetic resonance imaging and... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Kumari A, Mishra GV, Parihar PH and Dudhe S. A prospective observational role of magnetic resonance imaging and magnetic resonance spectroscopy in evaluation of choline levels in gall bladder carcinoma in tertiary care hospital in central India [version 1; peer review: 1 approved] . F1000Research 2024, 13 :541 ( https://doi.org/10.12688/f1000research.149919.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol A prospective observational role of magnetic resonance imaging and magnetic resonance spectroscopy in evaluation of choline levels in gall bladder carcinoma in tertiary care hospital in central India [version 1; peer review: 1 approved] Anjali Kumari https://orcid.org/0009-0005-6942-2900 1 , Gaurav V Mishra 1 , P.H. Parihar 1 , Sakshi Dudhe https://orcid.org/0009-0008-9176-4044 1 Anjali Kumari https://orcid.org/0009-0005-6942-2900 1 , Gaurav V Mishra 1 , P.H. Parihar 1 , Sakshi Dudhe https://orcid.org/0009-0008-9176-4044 1 PUBLISHED 28 May 2024 Author details Author details 1 Radiodiagnosis, Datta Meghe Institute of Higher Education & Research, Wardha, 442001, India Anjali Kumari Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Gaurav V Mishra Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing P.H. Parihar Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Sakshi Dudhe Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Datta Meghe Institute of Higher Education and Research collection. Abstract Background Gall bladder carcinoma (GBC) is a challenging malignancy characterized by late-stage diagnosis and poor prognosis. Early detection and accurate staging are crucial for improving patient outcomes. Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) offer non-invasive imaging modalities that may aid in the evaluation of GBC. Choline, a metabolite detected by MRS, has been implicated in tumor growth and may serve as a potential biomarker for GBC. This study aims to investigate the role of MRI and MRS in evaluating choline levels as biomarkers for GBC. Method A prospective observational study will be conducted involving patients with suspected or confirmed GBC referred to the Department of Radiology, AVBRH, Sawangi. Patients meeting inclusion criteria will undergo MRI scans and MRS examinations to assess tumor characteristics and choline levels. Data collected will include MRI images, MRS spectra, histopathological results, and clinical outcomes. Statistical analysis will be performed to examine correlations between MRI findings, choline levels, and histopathological characteristics. Expected Outcome It is anticipated that MRI and MRS will demonstrate utility in evaluating choline levels as imaging biomarkers for GBC. Correlations between choline levels, tumor characteristics, and clinical outcomes are expected to provide valuable insights into the role of choline in GBC pathogenesis and prognosis. If successful, MRI and MRS could serve as non-invasive tools for early detection, staging, and treatment response monitoring in GBC, ultimately leading to improved patient outcomes and management strategies. READ ALL READ LESS Keywords Gall bladder carcinoma, MRI, MR spectroscopy, Choline levels, Biomarkers, Early detection Corresponding Author(s) Anjali Kumari ( [email protected] ) Close Corresponding author: Anjali Kumari Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2024 Kumari A et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Kumari A, Mishra GV, Parihar PH and Dudhe S. A prospective observational role of magnetic resonance imaging and magnetic resonance spectroscopy in evaluation of choline levels in gall bladder carcinoma in tertiary care hospital in central India [version 1; peer review: 1 approved] . F1000Research 2024, 13 :541 ( https://doi.org/10.12688/f1000research.149919.1 ) First published: 28 May 2024, 13 :541 ( https://doi.org/10.12688/f1000research.149919.1 ) Latest published: 28 May 2024, 13 :541 ( https://doi.org/10.12688/f1000research.149919.1 ) Background Gallbladder carcinoma (GBC) is a relatively rare but highly aggressive malignancy of the biliary tract with a poor prognosis, mainly due to its often late diagnosis and limited treatment options. 1 Early detection and accurate staging of GBC are crucial for improving patient outcomes. Yet, conventional imaging modalities like ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI) have limitations in precisely characterizing tumor extent and aggressiveness. 2 Recent advances in MRI, coupled with magnetic resonance spectroscopy (MRS), have shown promise in enhancing the diagnostic accuracy and prognostic value for various cancers, including hepatobiliary malignancies. 3 MRS enables the non-invasive assessment of metabolite levels within tissues, offering insights into cellular metabolism and providing potential biomarkers for cancer detection and characterization. 4 One such metabolite of interest is choline, a component of cell membranes whose elevated levels have been associated with increased cell proliferation and malignant transformation. 5 Despite the growing interest in utilizing MRI and MRS for GBC evaluation, there remains a need for further research to validate their utility, particularly regarding choline levels as a biomarker for tumor detection and characterization. Therefore, this study aims to investigate the role of MRI and MR spectroscopy in evaluating choline levels in GBC to improve early detection and guide personalized treatment strategies for this aggressive malignancy. Aim This study aims to investigate the role of MRI and MR spectroscopy in evaluating choline levels in gall bladder carcinoma. Objectives 1. To assess the spectrum of MRI findings in patients diagnosed with gall bladder carcinoma. 2. To determine choline levels using MR spectroscopy in gall bladder carcinoma. 3. To evaluate the diagnostic accuracy of MRI in assessing the size, resectability, and vascular involvement of gall bladder carcinoma. 4. To explore the potential of MR spectroscopy in detecting choline levels as a biomarker for gall bladder carcinoma. 5. To assess the feasibility and safety of performing MRI and MR spectroscopy in patients with gall bladder carcinoma. 6. To investigate any correlation between choline levels detected by MR spectroscopy and histopathological findings in gall bladder carcinoma. 7. To contribute to understanding the role of imaging techniques in the early detection and management of gall bladder carcinoma. Method Study design This study will utilize a prospective observational design to evaluate the role of MRI and MR spectroscopy in assessing choline levels in gall bladder carcinoma. Patients meeting the inclusion criteria will undergo MRI scans, and MR spectroscopy will be conducted to analyze choline levels. Data will be collected and analyzed to fulfill the study objectives. Study population The study population will include patients with suspected or diagnosed cases of gall bladder carcinoma. Inclusion criteria will involve patients who consent to participate, do not have contraindications for MRI or MR spectroscopy, and are referred to the Department of Radiology, AVBRH, Sawangi. Exclusion criteria will encompass patients with prior surgical or medical interventions, pregnant women, individuals with pacemakers or metallic implants, those with psychological conditions or claustrophobia, and those who are unwilling or uncooperative. Place of study The study will be conducted at the Department of Radiology, Acharya Vinoba Bhave Rural Hospital, Sawangi, under the auspices of Datta Meghe Institute of Higher Education and Research. AVBRH has the necessary infrastructure and facilities for conducting MRI scans and MR spectroscopy. The hospital serves as a referral center for patients in the region, ensuring access to a diverse patient population for the study. Inclusion criteria 1. Patients aged 18 years and above. 2. Patients with suspected or confirmed diagnosis of gall bladder carcinoma based on clinical evaluation, imaging studies, or biopsy results. 3. Patients willing to provide verbal and written informed consent for participation in the study. 4. Patients capable of undergoing MRI and MR spectroscopy examinations without contraindications. 5. Patients referred to the Department of Radiology, AVBRH, Sawangi, for further evaluation and management of gall bladder carcinoma. Exclusion criteria 1. Patients below the age of 18 years. 2. Patients with contraindications for MRI or MR spectroscopy, including those with metallic implants incompatible with MRI, pacemakers, cochlear implants, or other implanted devices. 3. Pregnant women or women who are breastfeeding. 4. Patients with a history of significant psychological conditions, including severe claustrophobia, that would impede the successful completion of the imaging procedures. 5. Patients who are unwilling or unable to provide informed consent for participation in the study. 6. Patients with prior surgical interventions or medical treatments for gall bladder carcinoma that may confound the study results. 7. Patients with concurrent medical conditions or comorbidities that could affect the interpretation of MRI or MR spectroscopy findings or compromise patient safety during the procedures. Enrollment process 1. Referral and Screening: Patients with suspected or confirmed diagnosis of gall bladder carcinoma will be referred to the Department of Radiology, AVBRH, Sawangi, by their primary care physicians, oncologists, or surgeons. Upon arrival, patients will undergo initial screening to assess their eligibility for participation in the study based on the inclusion and exclusion criteria. 2. Informed consent: Eligible patients will be provided with detailed information about the study objectives, procedures, potential risks, and benefits. They will be given ample time to ask questions and clarify any concerns. Verbal and written informed consent will be obtained from patients willing to participate in the study. 3. Baseline assessment: Patients who consent to participate will undergo a baseline assessment, including a review of their medical history, physical examination, and relevant laboratory investigations. This assessment will help ensure that patients meet the inclusion criteria and do not have any contraindications for MRI or MR spectroscopy. 4. MRI and MR spectroscopy: According to the study protocol, eligible patients will then be scheduled for MRI scans and MR spectroscopy examinations. Patients will be instructed on the procedure and asked to cooperate during the imaging sessions to ensure the quality of the obtained data. 5. Data collection: During MRI and MR spectroscopy examinations, data will be collected using the specified imaging sequences and protocols. Choline levels will be analyzed using MR spectroscopy, and MRI findings will be assessed for gall bladder carcinoma characteristics. 6. Follow-up: After completion of the imaging procedures, patients may receive further diagnostic or therapeutic interventions as per their clinical management plan. Followup appointments may be scheduled to monitor patients’ progress and evaluate treatment response. 7. Data analysis: Trained radiologists and researchers will analyze collected data, including MRI images and spectroscopy results, to fulfill the study objectives. Statistical analyses may assess correlations between choline levels, MRI findings, and histopathological results. 8. Enrollment completion: Enrollment will continue until the predetermined sample size is reached or the study duration is completed. Data analysis will be finalized upon enrollment completion, and study findings will be reported per the study protocol and ethical guidelines. Data collection procedure Data collection for this study will encompass several key components. Initially, baseline information will be gathered, including demographic data such as age, gender, ethnicity, and occupation, alongside a detailed clinical history. This will entail documenting symptoms, their duration, previous treatments, and any existing medical comorbidities. Laboratory investigations will also be recorded, including complete blood count, liver function tests, and tumor markers such as CA 19-9. Moreover, imaging reports from previous studies, such as ultrasounds or CT scans, will be reviewed to compile relevant findings related to gall bladder carcinoma. Subsequently, data collection will focus on MRI and MR spectroscopy. MRI images, including T1-weighted, T2-weighted, and diffusion-weighted images, will be obtained and assessed for various features indicative of gall bladder carcinoma, such as mass lesions or wall thickening. Additionally, MR spectroscopy data will be analyzed for choline peaks, providing quantitative measurements of choline concentration, a potential biomarker for gall bladder carcinoma. Histopathological data, if available, will also be included in the analysis. This will involve documenting the results of biopsies or surgical specimens, including the histopathological diagnosis of gall bladder carcinoma, tumor grade (well, moderately, or poorly differentiated), and tumor stage based on TNM staging. Followup data will be collected to monitor treatment responses and clinical outcomes. This will entail documenting the treatments received, such as surgery, chemotherapy, or radiotherapy, and assessing responses through radiological evaluations of tumor regression, stabilization, or progression. Additionally, patient survival status, recurrence of carcinoma, and progression-free survival will be recorded. Furthermore, the study will gather data on patient experiences and any adverse events encountered during MRI and MR spectroscopy procedures. Patient feedback regarding comfort levels and any discomfort or complications experienced will be documented to inform future improvements in patient care. Quality control measures will be implemented throughout the data collection process, including standardized imaging protocols, blinding of radiologists interpreting the data, and regular calibration of imaging equipment to ensure the accuracy and reliability of results. Finally, data management and analysis will involve entering collected data into a secure electronic database and statistical analysis using appropriate methods to examine relationships between variables. Ethical considerations, such as ensuring patient confidentiality, obtaining informed consent, and obtaining institutional review board approval, will be followed throughout the study. Sample size Determining the appropriate sample size is crucial for ensuring the study’s statistical power and the reliability of the findings. This study’s sample size calculation was based on the prevalence of gall bladder carcinoma and the desired confidence level and margin of error. Using the Cochran Formula, a sample size of 20 patients was determined, considering a prevalence rate of 1.2% and an error margin of 5%. This sample size provides sufficient statistical power to detect potential associations between MRI findings, choline levels, and gall bladder carcinoma characteristics with high confidence. Statistical methods The statistical analysis for this study will employ a range of methods to thoroughly examine the relationships between variables and assess the significance of the findings. Initially, descriptive statistics will be utilized to summarize the characteristics of the study population, encompassing demographic information, clinical features, and imaging findings. Measures such as means, standard deviations, frequencies, and percentages will be calculated to provide a comprehensive overview of the collected data, facilitating a clear understanding of the sample characteristics. Correlation analysis will then explore the strength and direction of relationships between key variables of interest. Specifically, correlations between MRI findings, choline levels measured by MR spectroscopy, and histopathological results will be assessed. Depending on the nature of the data, either Pearson correlation coefficients or Spearman’s rank correlation coefficients will be computed to quantify the degree of association between these variables. Regression analysis will be employed to investigate the predictive value of MRI findings and choline levels for various aspects of gall bladder carcinoma, such as tumor stage, grade, or treatment response. Multiple linear regression or logistic regression models may be utilized to determine the independent contributions of each variable in predicting specific outcomes, thereby elucidating their potential prognostic significance. Furthermore, comparative analysis will be performed to evaluate differences in MRI findings and choline levels across different subgroups of patients, categorized based on relevant factors such as tumor stage, grade, or treatment status. This analysis will utilize appropriate statistical tests, including t-tests, Mann-Whitney U tests, ANOVA, chi-square tests, or Fisher’s exact tests, depending on the type and distribution of the data. Survival analysis techniques, such as Kaplan-Meier curves and Cox proportional hazards models, may be employed to assess the impact of MRI findings and choline levels on patient survival outcomes, including overall and progression-free survival. These analyses will provide valuable insights into the prognostic significance of imaging biomarkers in gall bladder carcinoma. Additionally, receiver operating characteristic (ROC) analysis may be conducted to evaluate the diagnostic accuracy of MRI findings and choline levels in distinguishing between different stages or grades of gall bladder carcinoma. By calculating the area under the curve (AUC) values, the discriminatory power of these imaging biomarkers can be quantified, informing their clinical utility in disease diagnosis and management using R studio version 4.3.1. Dissemination After the completion of the study, we will publish it in an indexed journal or conference. Study status The study has yet to start. After the publication of the protocol, we will start recruiting for the study. Discussion Gall bladder carcinoma (GBC) poses a significant clinical challenge due to its often-asymptomatic nature in the early stages and aggressive behavior once symptomatic. Despite advancements in diagnostic modalities and treatment strategies, the prognosis for GBC remains poor, primarily due to late-stage diagnosis and limited effective treatment options. 6 In this study, we proposed to investigate the role of MRI and MR spectroscopy in evaluating choline levels as potential biomarkers for GBC, aiming to improve early detection and prognosis prediction. The use of MRI in the evaluation of GBC has shown promising results in previous studies. MRI provides high-resolution imaging of the gall bladder, allowing for detailed assessment of tumor size, local invasion, and vascular involvement. Additionally, MR spectroscopy offers the ability to measure choline levels within the tumor tissue, which may indicate malignancy. Choline is a key component of cell membrane metabolism and has been implicated in tumor growth and proliferation. Several studies have demonstrated elevated choline levels in various malignancies, including breast, prostate, and brain tumors. 7 Our study aims to build upon this knowledge by investigating the utility of MRI and MR spectroscopy in evaluating choline levels, specifically in GBC. By correlating MRI findings with choline levels measured by MR spectroscopy, we aim to identify imaging biomarkers that can aid in the early detection and characterization of GBC. Early detection is critical in improving patient outcomes, as surgical resection remains the primary curative treatment option for GBC. Moreover, accurate tumor aggressiveness and staging characterization can guide treatment decisions and prognosis prediction. 8 The proposed study will contribute to the growing body of literature on imaging biomarkers for GBC and may have implications for clinical practice. If successful, MRI and MR spectroscopy could be non-invasive tools for GBC diagnosis and staging, potentially reducing the need for invasive procedures such as biopsy or exploratory surgery. Additionally, quantifying choline levels in GBC tumors could aid treatment response monitoring and prognostication, leading to more personalized and effective patient management strategies. 9 However, several challenges and limitations must be considered. Firstly, the sample size in our study is relatively small, which may limit the generalizability of our findings. Future studies with larger cohorts are warranted to validate our results and establish robust diagnostic and prognostic models. 10 Secondly, MRI and MR spectroscopy techniques require specialized equipment and expertise, which may only be available in some clinical settings. Efforts to standardize imaging protocols and train healthcare professionals in these techniques will be crucial for widespread implementation. 11 Ethical and consent The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has approved the study protocol (Reference number: DMIHER/IEC/2023/768. Date: 21-03-2023). Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives. Data availability No data are associated with this article. References 1. Hundal R, Shaffer EA: Gallbladder cancer: epidemiology and outcome. Clin. Epidemiol. 2014; 6 : 99–109. PubMed Abstract | Publisher Full Text | Free Full Text 2. Ramachandran A, Srivastava DN, Madhusudhan KS: Gallbladder cancer revisited: the evolving role of a radiologist. Br. J. Radiol. 2021; 94 : 20200726. PubMed Abstract | Publisher Full Text | Free Full Text 3. Manfredi R, Barbaro B, Masselli G, et al. : Magnetic resonance imaging of cholangiocarcinoma. Semin. Liver Dis. 2004; 24 : 155–164. Publisher Full Text 4. Glunde K, Bhujwalla ZM, Ronen SM: Choline metabolism in malignant transformation. Nat. Rev. Cancer. 2011; 11 : 835–848. PubMed Abstract | Publisher Full Text | Free Full Text 5. Podo F: Tumour phospholipid metabolism. NMR Biomed. 1999; 12 : 413–439. <a target="xrefwindow" id="d1509e555" href="https://doi.org/10.1002/(sici)1099-1492(199911)12:7 Publisher Full Text 6. Dwivedi AND, Jain S, Dixit R: Gall bladder carcinoma: Aggressive malignancy with protean loco-regional and distant spread. World J. Clin. Cases. 2015; 3 : 231–244. PubMed Abstract | Publisher Full Text | Free Full Text 7. Soundararajan R, Marodia Y, Gupta P, et al. : Imaging patterns of wall thickening type of gallbladder cancer. Clin. Exp. Hepatol. 2022; 8 : 255–266. PubMed Abstract | Publisher Full Text | Free Full Text 8. Verma A, Kumar I, Verma N, et al. : Magnetic resonance spectroscopy — Revisiting the biochemical and molecular milieu of brain tumors. BBA Clin. 2016; 5 : 170–178. PubMed Abstract | Publisher Full Text | Free Full Text 9. Kauppinen RA, Peet AC: Using magnetic resonance imaging and spectroscopy in cancer diagnostics and monitoring. Cancer Biol. Ther. 2011; 12 : 665–679. PubMed Abstract | Publisher Full Text | Free Full Text 10. Biau DJ, Kernéis S, Porcher R: Statistics in Brief: The Importance of Sample Size in the Planning and Interpretation of Medical Research. Clin. Orthop. Relat. Res. 2008; 466 : 2282–2288. PubMed Abstract | Publisher Full Text | Free Full Text 11. Faber J, Fonseca LM: How sample size influences research outcomes. Dental Press J. Orthod. 2014; 19 : 27–29. PubMed Abstract | Publisher Full Text | Free Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 28 May 2024 ADD YOUR COMMENT Comment Author details Author details 1 Radiodiagnosis, Datta Meghe Institute of Higher Education & Research, Wardha, 442001, India Anjali Kumari Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Gaurav V Mishra Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing P.H. Parihar Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Sakshi Dudhe Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (1) version 1 Published: 28 May 2024, 13:541 https://doi.org/10.12688/f1000research.149919.1 Copyright © 2024 Kumari A et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Kumari A, Mishra GV, Parihar PH and Dudhe S. A prospective observational role of magnetic resonance imaging and magnetic resonance spectroscopy in evaluation of choline levels in gall bladder carcinoma in tertiary care hospital in central India [version 1; peer review: 1 approved] . F1000Research 2024, 13 :541 ( https://doi.org/10.12688/f1000research.149919.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 28 May 2024 Views 0 Cite How to cite this report: Justiz-Vaillant A. Reviewer Report For: A prospective observational role of magnetic resonance imaging and magnetic resonance spectroscopy in evaluation of choline levels in gall bladder carcinoma in tertiary care hospital in central India [version 1; peer review: 1 approved] . F1000Research 2024, 13 :541 ( https://doi.org/10.5256/f1000research.164433.r325722 ) The direct URL for this report is: https://f1000research.com/articles/13-541/v1#referee-response-325722 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 31 Oct 2024 Angel Justiz-Vaillant , Eric Williams Medical Science Complex, The University of the West Indies at St Augustine, Saint Augustine, Tunapuna/Piarco Municipal Corporation, Trinidad and Tobago Approved VIEWS 0 https://doi.org/10.5256/f1000research.164433.r325722 Clear Aim and Objectives: The study has a well-defined aim with clear objectives that are methodically outlined. Each objective supports the overall aim, providing a comprehensive approach to assessing MRI and MRS in GBC. Use of Non-Invasive ... Continue reading READ ALL Clear Aim and Objectives: The study has a well-defined aim with clear objectives that are methodically outlined. Each objective supports the overall aim, providing a comprehensive approach to assessing MRI and MRS in GBC. Use of Non-Invasive Techniques: MRI and MRS, as non-invasive diagnostic tools, are appropriate for the study's goals. MRS specifically targeting choline levels as a biomarker addresses an important area in cancer diagnosis with potential clinical implications. Ethical Considerations: The protocol outlines ethical practices, including obtaining consent and approval from the ethics committee. This ensures that the study complies with research ethics, protecting patient welfare. Structured Data Collection and Analysis Plan: The plan for data collection is systematic, with comprehensive details on patient demographics, imaging findings, and histopathological outcomes. Statistical methods are well chosen to analyze MRI and MRS findings, with additional provisions for ROC analysis to assess diagnostic accuracy, enhancing the study's rigor. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Oncology I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Justiz-Vaillant A. Reviewer Report For: A prospective observational role of magnetic resonance imaging and magnetic resonance spectroscopy in evaluation of choline levels in gall bladder carcinoma in tertiary care hospital in central India [version 1; peer review: 1 approved] . F1000Research 2024, 13 :541 ( https://doi.org/10.5256/f1000research.164433.r325722 ) The direct URL for this report is: https://f1000research.com/articles/13-541/v1#referee-response-325722 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 28 May 2024 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 Version 1 28 May 24 read Angel Justiz-Vaillant , The University of the West Indies at St Augustine, Saint Augustine, Trinidad and Tobago Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Justiz-Vaillant A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 31 Oct 2024 | for Version 1 Angel Justiz-Vaillant , Eric Williams Medical Science Complex, The University of the West Indies at St Augustine, Saint Augustine, Tunapuna/Piarco Municipal Corporation, Trinidad and Tobago 0 Views copyright © 2024 Justiz-Vaillant A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Clear Aim and Objectives: The study has a well-defined aim with clear objectives that are methodically outlined. Each objective supports the overall aim, providing a comprehensive approach to assessing MRI and MRS in GBC. Use of Non-Invasive Techniques: MRI and MRS, as non-invasive diagnostic tools, are appropriate for the study's goals. MRS specifically targeting choline levels as a biomarker addresses an important area in cancer diagnosis with potential clinical implications. Ethical Considerations: The protocol outlines ethical practices, including obtaining consent and approval from the ethics committee. This ensures that the study complies with research ethics, protecting patient welfare. Structured Data Collection and Analysis Plan: The plan for data collection is systematic, with comprehensive details on patient demographics, imaging findings, and histopathological outcomes. Statistical methods are well chosen to analyze MRI and MRS findings, with additional provisions for ROC analysis to assess diagnostic accuracy, enhancing the study's rigor. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Oncology I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Justiz-Vaillant A. Peer Review Report For: A prospective observational role of magnetic resonance imaging and magnetic resonance spectroscopy in evaluation of choline levels in gall bladder carcinoma in tertiary care hospital in central India [version 1; peer review: 1 approved] . F1000Research 2024, 13 :541 ( https://doi.org/10.5256/f1000research.164433.r325722) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. 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