Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions
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About
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.
Enrollment
Sex
Ages
Volunteers
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).
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Clinical Trials Referral Office
Data sourced from clinicaltrials.gov
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