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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 50Years - 74Years
FEMALE
Healthy Volunteers
ID05800132

Comparing Standard and AI-Assisted Second Reading for Breast Cancer Screening Mammograms in Women Aged 50 to 74

Led by Therapixel · Updated on 2024-04-12

5000

Participants Needed

7

Research Sites

108 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are comparing two methods for the second reading of screening mammograms in women aged 50 to 74 as part of a breast cancer screening program. The study aims to determine if the AI-assisted reading process is not worse than the standard radiologist reading and if it may be more cost-effective. It focuses on mammograms deemed normal or showing benign lesions from the first reading. Participants mammograms undergo two review paths the standard second reading by a certified radiologist, and an AI-assisted reading where mammograms flagged as suspicious by the AI are then reviewed by a radiologist. The final decision is based on the more concerning assessment from either method. Women will be recalled for further exams if either reading indicates suspicion. During the study, participants receive screening mammograms and their results are monitored for recall rate, cancer detection, sensitivity, specificity, economic impact, time to results, and reading time. The study will follow up for up to 48 months to measure these outcomes. Participants must consent and meet eligibility requirements related to health, imaging quality, and availability for the study duration.

CONDITIONS

Brief Title

Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI

Research Team

B

Brigitte Seradour

P

Patrice Heid

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