Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions

NCT07280312RecruitingNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Mayo Clinic

Enrollment

40

Start Date

2026-01-22

Completion Date

2027-12-17

Study Type

INTERVENTIONAL

Official Title

Ultrasound Imaging of Ovarian and Adnexal Lesions

Interventions

Transvaginal UltrasoundUltrasound Microvessel Imaging

Conditions

Female Reproductive System Adnexal NeoplasmOvarian CarcinomaFemale Reproductive System NeoplasmOvarian NeoplasmsAdnexal LesionOvarian Lesion

Eligibility

Age Range

18 Years+

Sex

FEMALE

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).

Outcome Measures

Primary Outcomes

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.

Time frame: Baseline

Locations

Mayo Clinic in Rochester, Rochester, United States

Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions