Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions
NCT07280312 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-02-03
Summary
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
- Female Reproductive System Adnexal Neoplasm
- Ovarian Carcinoma
- Female Reproductive System Neoplasm
- Ovarian Neoplasms
- Adnexal Lesion
- Ovarian Lesion
Interventions
- PROCEDURE
-
Transvaginal Ultrasound
Undergo transvaginal ultrasound
- PROCEDURE
-
Ultrasound Microvessel Imaging
Undergo UMI
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Shigao D. Chen, PhD · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-22
- Primary Completion
- 2027-12-17
- Completion
- 2029-12-17
Countries
- United States
Study Locations
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