Clinical trial · Interventional
Contrast-enhanced Ultrasound Evaluation of Indeterminate Ovarian Lesions: Prospective Multicenter Study
- Source
- ClinicalTrials.gov
- Retrieved
- Oct 1, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20261001-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adnexal Lesion | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-Enhanced Ultrasound (CEUS) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast-Enhanced Ultrasound (CEUS)
- description
- Participants with indeterminate or suspicious ovarian/adnexal lesions identified on routine US or MRI will undergo CEUS examinations within 2 months after their standard of care imaging or within 2 months prior to their standard of care surgery. The US contrast agent will be administered by bolus intravenous injection through a 18-22 Gauge angiocatheter placed in a peripheral arm vein ultrasound contrast agent, as per manufacturer's guidelines. During a single examination, a second injection will be administered, and imaging repeated using the same or different transducer. During the contrast injection the approximate lesion mid-line or the most vascular portion of the lesion will be imaged until homogenous enhancement is achieved (approximately 30-60 seconds post injection), followed by imaging sweeps through the lesion.. After that, intermittent imaging will be continued for 3 minutes, after which data will be digitally stored for later review.
- interventionNames
- Diagnostic Test: Contrast-Enhanced Ultrasound (CEUS)
Primary outcomes (4)
- measure
- Percentage of Participants with Ovarian Cancer Correctly Identified as Positive by Qualitative CEUS Biomarkers (Sensitivity)
- timeFrame
- Up to 1 year after CEUS examination
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available