Status:

RECRUITING

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

Lead Sponsor:

Therapixel

Conditions:

Breast Cancer

Eligibility:

FEMALE

50-74 years

Phase:

NA

Brief Summary

The goal of this clinical trial is to compare, for the second reading of screening mammograms, the standard of care with an AI assisted scenario. The main questions it aims to answer are: * will the...

Detailed Description

All mammograms eligible for a second reading, and included in the study, go through 2 arms: * Conventional second reading by a radiologist accredited to do second reading in France (L2 control arm), ...

Eligibility Criteria

Inclusion Criteria:

  • Affiliated to the French social security system
  • Whose mammograms meet the following characteristics: 4 (2 per breast, CC and MLO) meeting local regulatory standards and with correct DICOM metadata,
  • Whose mammograms have been determined to be normal or to have benign lesions by the radiologist who performed the first reading of the images (L1) in the framework of the organized breast cancer screening program
  • Having expressed her willingness to participate in the study, to undergo all the procedures and to make herself available for the expected duration of their participation,
  • Having completed and signed the informed consent form.

Exclusion Criteria:

  • Woman with breast implants,
  • With clinical symptoms of breast cancer,
  • With a history of breast surgery (breast reduction or surgery for benign lesion),
  • Pregnant or breastfeeding,
  • With medical conditions that may interfere with her ability to understand the requirements of the protocol or give informed consent,
  • Deprived of liberty by judicial or administrative order,
  • Participant whose mammogram images have at least one of the following defects: poor quality of the images, non-standard mammography (projection, magnification, compression), ML/LM/SIO/XCCL or XCCM view.

Key Trial Info

Start Date :

June 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

5000 Patients enrolled

Trial Details

Trial ID

NCT05800132

Start Date

June 1 2023

End Date

September 1 2027

Last Update

April 12 2024

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Centre de radiologie Les Défensions

Aubagne, France

2

Var Imagerie Medicale

Draguignan, France

3

VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper

Fréjus, France

4

VAR IMAGERIE MEDICALE - Clinique Les Lauriers

Fréjus, France