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

Last updated: April 11, 2024
Sponsor: Therapixel
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

MammoScreen

Clinical Study ID

NCT05800132
ID-RCB 2022-A01488-35
  • Ages 50-74
  • Female
  • Accepts Healthy Volunteers

Study 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 experimental pathway be non-inferior to the standard pathway?

  • will the experimental pathway be economically superior to the standard pathway?

Participants will receive screening mammograms, as part of the breast cancer screening program. Researchers will compare the interpretation made by the second reader in the standard pathway with the AI assisted interpretation made by a different reader in the experimental pathway.

Eligibility Criteria

Inclusion

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 theradiologist who performed the first reading of the images (L1) in the framework of theorganized breast cancer screening program
  • Having expressed her willingness to participate in the study, to undergo all theprocedures and to make herself available for the expected duration of theirparticipation,
  • Having completed and signed the informed consent form.

Exclusion

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 therequirements 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: poorquality of the images, non-standard mammography (projection, magnification,compression), ML/LM/SIO/XCCL or XCCM view.

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: MammoScreen
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
September 30, 2027

Study 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),

  • Second reading assisted by the AI (L2-AI experimental arm): mammograms will be read by the AI first and only if deemed suspicious, a radiologist accredited to do second reading in France will review them.

The most pejorative assessment among the two arms is used as the final decision: if both arms consider the mammogram as negative, the participant won't be recalled, if one arm consider the mammogram as positive, the participant will be called back for further examinations.

Clinical performances and economical impacts of both scenarii will be compared.

Connect with a study center

  • Centre de radiologie Les Défensions

    Aubagne,
    France

    Active - Recruiting

  • Var Imagerie Medicale

    Draguignan,
    France

    Active - Recruiting

  • VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper

    Fréjus,
    France

    Active - Recruiting

  • VAR IMAGERIE MEDICALE - Clinique Les Lauriers

    Fréjus,
    France

    Active - Recruiting

  • Cabinet de Radiologie du Cabot

    Marseille,
    France

    Completed

  • Centre de Sénologie Mermoz

    Marseille,
    France

    Active - Recruiting

  • VAR IMAGERIE MEDICALE - Cabinet de Radiologie de la Gare

    Saint-Raphaël,
    France

    Site Not Available

  • VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon

    Saint-Raphaël,
    France

    Active - Recruiting

  • Var Imagerie Medicale

    Sainte-Maxime,
    France

    Site Not Available

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