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Non-Invasive identification of Endometrial Cancer/Endometrial Atypical Hyperplasia with an AI-Based Classifier applied to Transvaginal Ultrasound in Patients with Post-Menopausal Bleeding
Trial Status: active
This study evaluates if AI can be used with transvaginal ultrasound images for early detection of endometrial cancer or premalignant lesions.
Inclusion Criteria
* Age ≥ 55 years
* At least one episode of PMB
* Endometrial biopsy available from Mayo Clinic (MN, AZ, FL), 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 TVUS
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06365905.
I. Prospective validation of an artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS) to identify patients with premalignant/malignant in a population of women with PMB.
OUTLINE: This is an observational study.
Patients undergo a transvaginal ultrasound examination and endometrial sampling per standard of care and have their medical records reviewed on study.
