Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07280312
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transvaginal Ultrasound — PROCEDURE
    Undergo transvaginal ultrasound
  • Ultrasound Microvessel Imaging — PROCEDURE
    Undergo UMI

Study Details

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.

Key Dates

Start date
Jan 22, 2026
Status verified
Jan 2026
Primary completion
Dec 17, 2027
Completion
Dec 17, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Diagnostic (UMI, transvaginal ultrasound)
    Patients undergo UMI during standard transvaginal ultrasound imaging procedure on study.

Primary Outcome Measure

Change in O-RADS score [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Shigao D. Chen, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Mayo Clinic in Rochester· Rochester, MN

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