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

Breast Cancer Clinical Trial

— IMA-L2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05800132
• Other study ID #: ID-RCB 2022-A01488-35
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: September 2027

Study information

• Verified date: April 2024
• Source: Therapixel
• Contact: Brigitte Seradour
• Phone: 06 09 88 38 64
• Email: brigitteseradour[@]hotmail.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: September 2027
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• MammoScreen
Diagnostic reading aid for breast cancer screening

Locations

Country	Name	City	State
France	Centre de radiologie Les Défensions	Aubagne
France	Var Imagerie Medicale	Draguignan
France	VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper	Fréjus
France	VAR IMAGERIE MEDICALE - Clinique Les Lauriers	Fréjus
France	Cabinet de Radiologie du Cabot	Marseille
France	Centre de Sénologie Mermoz	Marseille
France	VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon	Saint-Raphaël

Sponsors (1)

Lead Sponsor	Collaborator
Therapixel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recall rate	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	Cancer detection rate	Number of biopsy proven cancers divided by the total number of patient receiving a second reading	End of the inclusion period 24 months
Secondary	Sensitivity and Specificity	True and false-positive rate	End of the follow_up period 48 months
Secondary	Economic impact	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
Secondary	Time-to-results	Time period [in days] between the day of the screening and the access to results	End of the inclusion period 24 months
Secondary	Reading time	Time needed [in seconds] to interpret a mammogram	End of the inclusion period 24 months