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NCT07849543Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 30 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
190 (estimated)
First submitted
24 Sept 2026
Start date
Oct 2026
Primary completion date
Jan 2031
Lead sponsor
Thomas Jefferson University
NCT number
NCT07849543

What you commit to

  • Study type: Interventional
  • Planned participants: 190
  • From Oct 2026 to the primary completion date, Jan 2031
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Subjects with any of the following will be excluded from this trial:
    • Patients with physiological or definitely benign ovarian or adnexal lesions (O-RADS 1-2).
    • Patients who are pregnant or lactating.
    • Patients with ovarian or adnexal lesions less than 1 cm or greater than 15 cm in size.
    • Patients with contraindications to CEUS.
    • Patients who are medically unstable, terminally ill, or whose clinical course is unpredictable.

Who the study is looking for

  • All subjects accepted for this trial must be:
    • Patients ≥ 18 years of age.
    • Capable of making informed decisions regarding her treatment.
    • Have an ovarian or adnexal lesion categorized as O-RADS US 3-5 on conventional US, OR
    • Have an ovarian or adnexal lesion categorized as O-RADS MRI 3-5 on pelvic MRI

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.