Back to resultsDiagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI (IMA-L2)
Primary Purpose
Breast Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MammoScreen
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer focused on measuring artificial intelligence, breast cancer screening, second reading
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.
Sites / Locations
- Centre de radiologie Les Défensions
- Var Imagerie Medicale
- VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper
- VAR IMAGERIE MEDICALE - Clinique Les Lauriers
- Cabinet de Radiologie du Cabot
- VAR IMAGERIE MEDICALE - Cabinet de Radiologie de la Gare
- VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon
- Var Imagerie Medicale
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
L2 - Standard second read
L2-AI - AI-assisted second read
Arm Description
Interpretation of mammograms done by a radiologist accredited to do second reading in France.
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.
Outcomes
Primary Outcome Measures
Recall rate
Number of patients that are called back for further examinations divided by the total number of patient receiving a second reading.
Secondary Outcome Measures
Cancer detection rate
Number of biopsy proven cancers divided by the total number of patient receiving a second reading
Sensitivity and Specificity
True and false-positive rate
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
Time-to-results
Time period [in days] between the day of the screening and the access to results
Reading time
Time needed [in seconds] to interpret a mammogram
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05800132
Brief Title
Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Therapixel
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
artificial intelligence, breast cancer screening, second reading
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
L2 - Standard second read
Arm Type
No Intervention
Arm Description
Interpretation of mammograms done by a radiologist accredited to do second reading in France.
Arm Title
L2-AI - AI-assisted second read
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MammoScreen
Intervention Description
Diagnostic reading aid for breast cancer screening
Primary Outcome Measure Information:
Title
Recall rate
Description
Number of patients that are called back for further examinations divided by the total number of patient receiving a second reading.
Time Frame
End of the inclusion period 24 months
Secondary Outcome Measure Information:
Title
Cancer detection rate
Description
Number of biopsy proven cancers divided by the total number of patient receiving a second reading
Time Frame
End of the inclusion period 24 months
Title
Sensitivity and Specificity
Description
True and false-positive rate
Time Frame
End of the follow_up period 48 months
Title
Economic impact
Description
Difference in direct medical costs between the two arms Difference in annual budgetary impact on the French National Health Insurance between the two arms
Time Frame
End of the follow_up period 48 months
Title
Time-to-results
Description
Time period [in days] between the day of the screening and the access to results
Time Frame
End of the inclusion period 24 months
Title
Reading time
Description
Time needed [in seconds] to interpret a mammogram
Time Frame
End of the inclusion period 24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brigitte Seradour
Phone
06 09 88 38 64
Email
brigitteseradour@hotmail.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Patrice Heid
Phone
06 09 07 83 67
Email
p.heid@depistage-cancerssud.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte Seradour
Organizational Affiliation
Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Région Sud PACA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de radiologie Les Défensions
City
Aubagne
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francoise LECRIVAIN
Facility Name
Var Imagerie Medicale
City
Draguignan
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent SIMONI
Facility Name
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper
City
Fréjus
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Eve BAQUE
Facility Name
VAR IMAGERIE MEDICALE - Clinique Les Lauriers
City
Fréjus
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent CAUDMONT
Facility Name
Cabinet de Radiologie du Cabot
City
Marseille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eliane DALMAS
Facility Name
VAR IMAGERIE MEDICALE - Cabinet de Radiologie de la Gare
City
Saint-Raphaël
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence GERMAIN
Facility Name
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon
City
Saint-Raphaël
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaux POIRIER
Facility Name
Var Imagerie Medicale
City
Sainte-Maxime
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel PROVOST
12. IPD Sharing Statement
Plan to Share IPD
No
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Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
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