Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions

NCT07280312 | Recruiting

• 2 other identifiers: 25-008495NCI-2025-08526
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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; Ovarian Lesion

Outcome Measures

Primary Outcomes (1)

• Change in O-RADS score

  Ovarian-Adnexal Reporting and Data System (O-RADS) scores will be initially based on B-mode and Doppler imaging (standard of care) obtained prior to surgical treatment. Radiologists will then review ultrasound microvessel imaging (UMI) images and may choose to revise the score. Accuracy of score adjustments will be assessed using final pathology results from the participant's medical record.

  Baseline

Study Arms (1)

Diagnostic (UMI, transvaginal ultrasound)

EXPERIMENTAL

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

Procedure: Transvaginal Ultrasound; Procedure: Ultrasound Microvessel Imaging

Interventions

Transvaginal Ultrasound PROCEDURE

Undergo transvaginal ultrasound

Also known as: transvaginal sonography, TVS, TVU

Diagnostic (UMI, transvaginal ultrasound)

Ultrasound Microvessel Imaging PROCEDURE

Undergo UMI

Also known as: 3D Ultrasound Microvessel Imaging, UMI

Diagnostic (UMI, transvaginal ultrasound)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged ≥ 18 years
• Scheduled for surgery for ovarian or adnexal lesions

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Ovarian Neoplasms; Genital Neoplasms, Female

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Shigao D. Chen, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 12, 2025
• Study Start: January 22, 2026
• Primary Completion (Estimated): December 17, 2027
• Study Completion (Estimated): December 17, 2029
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)