Using AI with Ultrasound to Detect Endometrial Cancer in Post-Menopausal Women
Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding
This study is testing whether an AI program can help find endometrial cancer in women over 55 who have had postmenopausal bleeding by looking at ultrasound images.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 55 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 3 sites (Scottsdale, Arizona and 2 other locations) |
| Trial ID | NCT06365905 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate an artificial intelligence (AI) algorithm that analyzes transvaginal ultrasound (TVUS) images to identify women with endometrial cancer or premalignant lesions. Participants will undergo a TVUS examination and have their medical records reviewed, including endometrial biopsy results. The study focuses on women aged 55 and older who have experienced postmenopausal bleeding, assessing the effectiveness of AI in early detection.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 55 and older who have experienced at least one episode of postmenopausal bleeding.
Not a fit: Patients who have had diagnostic tests performed more than 90 days apart or those unable to undergo a transvaginal ultrasound may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate detection of endometrial cancer, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using AI for medical imaging, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 55 years * At least one episode of postmenopausal bleeding (PMB) * Endometrial biopsy available from at Mayo Clinic (MN, AZ, FL), Mayo Clinic Health System (MCHS), or an external institution * Acceptance to participate in the study Exclusion Criteria: * Diagnostic tests performed more than 90 days apart * Physical impediment/refusal to undergo transvaginal ultrasound (TVUS)
Where this trial is running
Scottsdale, Arizona and 2 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Gretchen E Glaser, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.