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Contrast-enhanced Ultrasound Evaluation of Indeterminate Ovarian Lesions: Prospective Multicenter Study

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
The goal of this clinical trial is to learn how well contrast-enhanced ultrasound (CEUS) can diagnose ovarian cancer in patients with indeterminate or suspicious ovarian/adnexal lesions identified on routine ultrasound or MRI. The main questions it aims to answer are: How accurately can qualitative CEUS imaging features distinguish malignant from benign ovarian/adnexal lesions? How consistent are the CEUS assessments among different readers, and can combining CEUS findings with MRI and clinical information improve diagnostic performance? Participants will: Undergo a baseline pelvic ultrasound followed by CEUS imaging using an intravenous ultrasound contrast agent. Receive a second contrast injection during the same examination so that additional CEUS images can be obtained. Be followed for up to 1 year, with standard-of-care imaging or pathology used as the reference for determining whether the ovarian/adnexal lesion is benign or malignant.
Trial Details
NCT Number NCT07849543
Lead Sponsor Thomas Jefferson University
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)
Ovarian Cancer, Adnexal Lesion
Related terms Ovarian Neoplasms
Enrollment 190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov