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

NCT ID: NCT05800132

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2027-09-30

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 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.

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),
• 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

L2 - Standard second read

Interpretation of mammograms done by a radiologist accredited to do second reading in France.

Group Type: NO_INTERVENTION

No interventions assigned to this group

L2-AI - AI-assisted second read

Interpretation of mammograms done by the AI-based device. Mammograms deemed suspicious by the AI (i.e., receiving an AI global score higher than a defined threshold) will be interpreted by a radiologist accredited to do second reading in France. Mammograms assessed as negative or low suspicious by the AI won't be further interpreted by a radiologist.

Group Type: EXPERIMENTAL

MammoScreen

Intervention Type: DEVICE

Diagnostic reading aid for breast cancer screening

Interventions

MammoScreen

Diagnostic reading aid for breast cancer screening

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Therapixel

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brigitte Seradour

Role: PRINCIPAL_INVESTIGATOR

Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Région Sud PACA

Locations

Centre de radiologie Les Défensions

Aubagne, , France

Site Status: RECRUITING

Var Imagerie Medicale

Draguignan, , France

Site Status: RECRUITING

VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper

Fréjus, , France

Site Status: RECRUITING

VAR IMAGERIE MEDICALE - Clinique Les Lauriers

Fréjus, , France

Site Status: RECRUITING

Cabinet de Radiologie du Cabot

Marseille, , France

Site Status: COMPLETED

Centre de Sénologie Mermoz

Marseille, , France

Site Status: RECRUITING

VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon

Saint-Raphaël, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Brigitte Seradour

Role: CONTACT

brigitteseradour@hotmail.fr

06 09 88 38 64

Patrice Heid

Role: CONTACT

p.heid@depistage-cancerssud.org

06 09 07 83 67

Facility Contacts

Francoise LECRIVAIN

Role: primary

Laurent SIMONI

Role: primary

Marie-Eve BAQUE

Role: primary

Laurent CAUDMONT

Role: primary

Aurelie JALAGUIER

Role: primary

Margaux POIRIER

Role: primary

Other Identifiers

ID-RCB 2022-A01488-35

Identifier Type: -

Identifier Source: org_study_id