Adnexal Lesion, Female Reproductive System Adnexal Neoplasm, Female Reproductive System Neoplasm, Ovarian Carcinoma, Ovarian Lesion, Ovarian Neoplasms
Conditions
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.
Interventions
PROCEDURETransvaginal Ultrasound
Undergo transvaginal ultrasound
PROCEDUREUltrasound Microvessel Imaging
Undergo UMI
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in O-RADS score | 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. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORShigao D. Chen, PhD
Mayo Clinic
Outcome results
None listed