Clinical trial · Interventional
Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions
Ultrasound Imaging of Ovarian and Adnexal Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial studies how well ultrasound microvessel imaging (UMI) works in evaluating ovarian and adnexal lesions in patients who are scheduled to have surgical treatment for their ovarian or adnexal lesions as part of their clinical care. Ovarian cancer is the most lethal gynecologic malignancy, often diagnosed at an advanced stage. Current diagnostic tools include a blood test (serum cancer antigen 125 \[CA125\]) and transvaginal ultrasound. However, CA125 has limited diagnostic accuracy and is Food and Drug Administration-approved only for monitoring the return of cancer (recurrence), not for preoperative diagnosis. A key measurement in calculating ovarian and adnexal cancer risk is by looking at increased blood flow, which may suggest a higher risk of cancer developing. However, current ultrasound techniques have limited ability to assess blood flow. A new ultrasound technique, UMI, may have higher sensitivity for detecting small blood vessels compared to traditional ultrasound imaging.
Conditions
Conditions (6)
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 | — |
| Female Reproductive System Adnexal Neoplasm | Female Reproductive System Adnexal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Female Reproductive System Neoplasm | Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Lesion | — | UNRESOLVED | — |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transvaginal Ultrasound | Procedure | — | UNRESOLVED |
| Ultrasound Microvessel Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (UMI, transvaginal ultrasound)
- description
- Patients undergo UMI during standard transvaginal ultrasound imaging procedure on study.
- interventionNames
- Procedure: Transvaginal Ultrasound
- Procedure: Ultrasound Microvessel Imaging
Primary outcomes (1)
- measure
- Change in O-RADS score
- timeFrame
- Baseline
- description
- Ovarian-Adnexal Reporting and Data System (O-RADS) scores will be initially based on B-mode and Doppler imaging (standard of care) obtained prior to surgical treatment. Radiologists will then review ultrasound microvessel imaging (UMI) images and may choose to revise the score. Accuracy of score adjustments will be assessed using final pathology results from the participant's medical record.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged ≥ 18 years * Scheduled for surgery for ovarian or adnexal lesions Exclusion Criteria: * Prior surgical removal of ovarian or adnexal lesions * Undergoing neoadjuvant chemotherapy or targeted systemic therapy * Vulnerable populations, including prisoners, adults lacking capacity to consent, and pregnant women (our study coordinator will ask participants if they are pregnant; if uncertain, a urine pregnancy test will be offered at no cost).
References
Publications (0)
Data not yet available