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NCT Number: NCT07280312

Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions

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.

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Key information

Conditions

Female Reproductive System Adnexal Neoplasm Adnexal Diseases Adnexal Lesion Endocrine Gland Neoplasms Endocrine System Diseases Female Reproductive System Neoplasm Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Carcinoma Ovarian Diseases Ovarian Lesion Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Shigao D. Chen, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Transvaginal Ultrasound

Procedure

Undergo transvaginal ultrasound

Other names: transvaginal sonography, TVS, TVU

Ultrasound Microvessel Imaging

Procedure

Undergo UMI

Other names: 3D Ultrasound Microvessel Imaging, UMI

Primary outcomes

  1. Change in O-RADS score

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Ultrasound Imaging of Ovarian and Adnexal Lesions

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Dec 12, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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