Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
Study NCT ID:
NCT05800132
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
Sponsor:
Therapixel
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMA-L2
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: