Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

Female patients aged ≥ 18 years

Scheduled for surgery for ovarian or adnexal lesions

Disqualifiers

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

Treatments tested in this trial

  • Transvaginal Ultrasound
  • Ultrasound Microvessel Imaging

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators