Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI (IMA-L2)

April 11, 2024 updated by: Therapixel

Évaluation de la Performance Diagnostique du dépistage du Cancer du Sein, Pour Une Seconde Lecture Des clichés de Mammographie assistée du Dispositif médical à Base d'Intelligence Artificielle MammoScreen

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

5000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Aubagne, France
        • Recruiting
        • Centre de radiologie Les Défensions
        • Contact:
          • Francoise LECRIVAIN
      • Draguignan, France
        • Recruiting
        • Var Imagerie Medicale
        • Contact:
          • Laurent SIMONI
      • Fréjus, France
        • Recruiting
        • VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper
        • Contact:
          • Marie-Eve BAQUE
      • Fréjus, France
        • Recruiting
        • VAR IMAGERIE MEDICALE - Clinique Les Lauriers
        • Contact:
          • Laurent CAUDMONT
      • Marseille, France
        • Completed
        • Cabinet de Radiologie du Cabot
      • Marseille, France
        • Recruiting
        • Centre de Sénologie Mermoz
        • Contact:
          • Aurelie JALAGUIER
      • Saint-Raphaël, France
        • Recruiting
        • VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon
        • Contact:
          • Margaux POIRIER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: L2 - Standard second read
Interpretation of mammograms done by a radiologist accredited to do second reading in France.
Experimental: 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.
Device: MammoScreen
Diagnostic reading aid for breast cancer screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recall rate
Time Frame: End of the inclusion period 24 months
Number of patients that are called back for further examinations divided by the total number of patient receiving a second reading.
End of the inclusion period 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer detection rate
Time Frame: End of the inclusion period 24 months
Number of biopsy proven cancers divided by the total number of patient receiving a second reading
End of the inclusion period 24 months
Sensitivity and Specificity
Time Frame: End of the follow_up period 48 months
True and false-positive rate
End of the follow_up period 48 months
Economic impact
Time Frame: End of the follow_up period 48 months
Difference in direct medical costs between the two arms Difference in annual budgetary impact on the French National Health Insurance between the two arms
End of the follow_up period 48 months
Time-to-results
Time Frame: End of the inclusion period 24 months
Time period [in days] between the day of the screening and the access to results
End of the inclusion period 24 months
Reading time
Time Frame: End of the inclusion period 24 months
Time needed [in seconds] to interpret a mammogram
End of the inclusion period 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Therapixel

Investigators

  • Principal Investigator: Brigitte Seradour, Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Région Sud PACA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID-RCB 2022-A01488-35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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