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

ConditionsOvarian Cancer Adnexal Lesion

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorThomas Jefferson University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Contrast-Enhanced Ultrasound (CEUS)
Diagnostic test
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.

Treatment groups

190 Participants

are divided into 1 treatment group

Group A: Contrast-Enhanced Ultrasound (CEUS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Percentage of Participants with Ovarian Cancer Correctly Identified as Positive by Qualitative CEUS Biomarkers (Sensitivity)

Sensitivity will be calculated for CEUS biomarkers compared to the composite reference standard (histopathology or follow-up imaging). Exact binomial confidence intervals (95%) will be calculated for all performance metrics. CEUS biomarker performance will be compared to standard MRI using McNemar's test for paired proportions.

Time frame