Evaluation of the Potential Impact of an Artificial Intelligence Solution in Second Reading of Organized Screening.

GCS Ramsay Santé pour l'Enseignement et la Recherche55,589 enrolled

Overview

Based on data from a series of patients who underwent screening mammography with a "normal" or "benign" first-reading result. The main objective of the study is to evaluate the possibilities of subtracting from the second reading of breast cancer screening a population of examinations for which the risk of discovering cancer is close to zero, using an AI system (here the MammoScreen™ system).

This is a retrospective multicenter study of mammography imaging data contained in the PACS (Picture Archiving and Communication System) of six radiology centers located in the Rhône, Puy de dôme, Cantal and Haute-Loire départements. In order to be able to collect two-year follow-up data, the files analyzed will concern all women who received a screening mammogram during the years 2015, 2016, 2017, 2018 and 2019. More recent mammograms will be excluded.

Study Type

OBSERVATIONAL

Enrollment

55,589

Conditions

Breast Cancer Female

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women aged 50 to 74 participating in the organized screening campaign. * Having had a screening mammogram with a final L1 result of "normal" (ACR 1/ BI-RADS 1) or "benign" (ACR 2/ BI-RADS 2). * For which a second reading interpretation is available * Screening mammograms performed during the years 2015 to2019 (In order to have follow-up data (subsequent mammogram or information on the person's future) Exclusion Criteria: \- Mammography not performed as part of organized screening

Locations (1)

Hôpital Privé Jean Mermoz

Lyon, France

Outcomes

Primary Outcomes

Percentage of real negatives

Percentage of cases negatived by MammoScreen (considered benign by the system), and for which no cancer was detected at the end of the L2 (according to the different risk levels of the MammoScreen software - score from 1 to 10). We distinguish two sub-populations: L2- and L2+ with BDD- (in addition to L2-).

Time frame: Week 8

Secondary Outcomes

Percentage of real positives

Percentage of MammoScreen-positive cases for which cancer was detected in L2 (according to the different risk levels of the MammoScreen software - score from 1 to 10).

Time frame: Week 8

Percentage of false negatives

Percentage of MammoScreen-positive cases with an L2 ultimately considered negative (L2- or L2 + with DBB-), for which interval cancer is detected (according to the different risk levels of the MammoScreen software - score from 1 to 10).

Time frame: Week 8

Data from ClinicalTrials.gov

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