Recruiting

Ultrasound Microvessel Imaging

Sponsor:

Mayo Clinic

Code:

NCT07280312

Conditions

Female Reproductive System Adnexal Neoplasm

Ovarian Carcinoma

Female Reproductive System Neoplasm

Ovarian Neoplasms

Adnexal Lesion

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transvaginal Ultrasound

Ultrasound Microvessel Imaging

Study Details

Brief 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

Study ID

NCT07280312

Start date

Jan 22, 2026

Status verified date

Jan, 2026

Completion date

Dec 17, 2029

Anticipated

Primary completion date

Dec 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (UMI, transvaginal ultrasound)

Patients undergo UMI during standard transvaginal ultrasound imaging procedure on study.

Interventions

Transvaginal Ultrasound

Undergo transvaginal ultrasound

Ultrasound Microvessel Imaging

Undergo UMI

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Shigao D. Chen, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-03.