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Contrast-enhanced Ultrasound Evaluation of Indeterminate Ovarian Lesions: Prospective Multicenter Study
Sponsor: Thomas Jefferson University
Summary
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2026-10
Completion Date
2031-07
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
Contrast-Enhanced Ultrasound (CEUS)
Participants will undergo contrast-enhanced ultrasound (CEUS) imaging of the ovarian/adnexal lesion. Lumason or Definity will be administered by intravenous bolus injection, followed by a saline flush. CEUS imaging will be performed following contrast administration. A second contrast injection will be administered during the same examination for repeat CEUS imaging.