OC157: Ovarian histoscanning, a new device to enhance ultrasound‐based clinical assessment of pelvic masses

Histoscanning (HS) is a medical device developed to improve interpretation of echography. Ovarian (OV) HistoScanning (OVHS) performs computerized analysis of voxel files generated during transvaginal ultrasonography (TVS). The targeted intended use is for the clinical assessment of pelvic masses in order to determine the type and timing, and improve the efficacy of exploratory surgeries. Thus, OVHS was designed to achieve a sensitivity of 100%. Women ≥ 18 years old scheduled to have complete removal of one or more ovaries were eligible. Exclusion criteria included previous diagnosis of cancer, pelvic surgery, radiotherapy or chemotherapy for breast or ovarian cancer. Real 3D-TVS were performed before surgery and the voxel data analyzed by OVHS. After registration of OVHS results in the study's database, pathology reports were reviewed and OVHS readings were compared to histology by an independent party. Analysis by the study's scientific steering committee of 269 data files in August 2005 reported the following: Pelvic histology: normal ovaries (87), benign tumors (78), past endometriosis (9), borderline cancers (21), adenocarcinomas (53), carcinomatosis (12), metastases (4) and other cancers (3), others (2). OVHS results: 91 cancers were correctly diagnosed by OVHS (sensitivity 98%). Reasons for false negatives were: lack of voxel data for the lesion (1) and pathology volume below US resolution (“Cystadenofibroma with foci of low malignant potential; Borderline”) (1). When electronical gain used during TVS was appropriate, the false positive (FP) rate was 3% for normal tissues and 17% for benign tumors. An identical study using 3D-TVS performed with controlled gain level is ongoing with results expected by July 2006. OVHS seems highly sensitive for the diagnosis of pelvic malignant masses while having an acceptable specificity.