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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-08526 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 25-008495 | Other Identifier | Mayo Clinic Institutional Review Board |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (UMI, transvaginal ultrasound) | Experimental | Patients undergo UMI during standard transvaginal ultrasound imaging procedure on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transvaginal Ultrasound | Procedure | Undergo transvaginal ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shigao D. Chen, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Ultrasound Microvessel Imaging | Procedure | Undergo UMI |
|
|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005833 | Genital Neoplasms, Female |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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