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Trial Title:
Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
NCT ID:
NCT05800132
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
artificial intelligence
breast cancer screening
second reading
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
MammoScreen
Description:
Diagnostic reading aid for breast cancer screening
Arm group label:
L2-AI - AI-assisted second read
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.
Criteria for 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.
Gender:
Female
Minimum age:
50 Years
Maximum age:
74 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Centre de radiologie Les Défensions
Address:
City:
Aubagne
Country:
France
Status:
Recruiting
Contact:
Last name:
Francoise LECRIVAIN
Facility:
Name:
Var Imagerie Medicale
Address:
City:
Draguignan
Country:
France
Status:
Recruiting
Contact:
Last name:
Laurent SIMONI
Facility:
Name:
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper
Address:
City:
Fréjus
Country:
France
Status:
Recruiting
Contact:
Last name:
Marie-Eve BAQUE
Facility:
Name:
VAR IMAGERIE MEDICALE - Clinique Les Lauriers
Address:
City:
Fréjus
Country:
France
Status:
Recruiting
Contact:
Last name:
Laurent CAUDMONT
Facility:
Name:
Cabinet de Radiologie du Cabot
Address:
City:
Marseille
Country:
France
Status:
Completed
Facility:
Name:
Centre de Sénologie Mermoz
Address:
City:
Marseille
Country:
France
Status:
Recruiting
Contact:
Last name:
Aurelie JALAGUIER
Facility:
Name:
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon
Address:
City:
Saint-Raphaël
Country:
France
Status:
Recruiting
Contact:
Last name:
Margaux POIRIER
Start date:
June 1, 2023
Completion date:
September 2027
Lead sponsor:
Agency:
Therapixel
Agency class:
Industry
Source:
Therapixel
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05800132
