Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-22

Study Completion Date

2029-12-17

Brief Summary

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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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Detailed Description

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Conditions

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Female Reproductive System Adnexal Neoplasm Ovarian Carcinoma Female Reproductive System Neoplasm Ovarian Neoplasms Adnexal Lesion Ovarian Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (UMI, transvaginal ultrasound)

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

Group Type EXPERIMENTAL

Transvaginal Ultrasound

Intervention Type PROCEDURE

Undergo transvaginal ultrasound

Ultrasound Microvessel Imaging

Intervention Type PROCEDURE

Undergo UMI

Interventions

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Transvaginal Ultrasound

Undergo transvaginal ultrasound

Intervention Type PROCEDURE

Ultrasound Microvessel Imaging

Undergo UMI

Intervention Type PROCEDURE

Other Intervention Names

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transvaginal sonography TVS TVU 3D Ultrasound Microvessel Imaging UMI

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No