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Recruiting NCT07280312

Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions

No phase Interventional Female Reproductive System Adnexal Neoplasm Ovarian Carcinoma Female Reproductive System Neoplasm Ovarian Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transvaginal Ultrasound, Ultrasound Microvessel Imaging.
Who it may be relevant to
Registry conditions: Female Reproductive System Adnexal Neoplasm, Ovarian Carcinoma, Female Reproductive System Neoplasm, Ovarian Neoplasms. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Ultrasound Imaging of Ovarian and Adnexal Lesions

Overview

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.

Interventions

  • Procedure Transvaginal Ultrasound
    Undergo transvaginal ultrasound
  • Procedure Ultrasound Microvessel Imaging
    Undergo UMI

Primary outcome measures

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

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07280312 · 25-008495 · NCI-2025-08526 · 25-008495

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗