Clinical trial NCT05800132: Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: artificial intelligence
breast cancer screening
second reading
Lead sponsor: Therapixel
Sponsor class: INDUSTRY
First posted: 2023-04-05
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Recall rate
timeFrame: End of the inclusion period 24 months
Secondary outcomes:
measure: Cancer detection rate
timeFrame: End of the inclusion period 24 months
measure: Sensitivity and Specificity
timeFrame: End of the follow_up period 48 months
measure: Economic impact
timeFrame: End of the follow_up period 48 months
measure: Time-to-results
timeFrame: End of the inclusion period 24 months
measure: Reading time
timeFrame: End of the inclusion period 24 months
Other outcomes:
Locations:
city: Aubagne
country: France
facility: Centre de radiologie Les Défensions
city: Draguignan
country: France
facility: Var Imagerie Medicale
city: Fréjus
country: France
facility: VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper
city: Fréjus
country: France
facility: VAR IMAGERIE MEDICALE - Clinique Les Lauriers
city: Marseille
country: France
facility: Cabinet de Radiologie du Cabot
city: Marseille
country: France
facility: Centre de Sénologie Mermoz
city: Saint-Raphaël
country: France
facility: VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon
Study officials:
affiliation: Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Région Sud PACA
name: Brigitte Seradour
role: PRINCIPAL_INVESTIGATOR
References: