AI-Assisted Second Reading of Mammograms for Breast Cancer
Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
Recruiting
N/AInterventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 74
Sex
Female
Study type
Interventional
Purpose
Screening
Participants needed
5,000 (estimated)
Sponsor
Therapixel · Industry
Who this trial is looking for
This trial is looking for women who have undergone screening mammograms to compare standard readings with AI-assisted readings. Participants will need to provide consent and be willing to undergo the study procedures.
Are You a Good Fit for This Trial?
You may be able to join if
I am affiliated with the French social security system.
My mammograms meet local regulatory standards.
My mammograms were found to be normal or have benign lesions.
I am willing to participate in the study.
I have completed and signed the informed consent form.
You may not be able to join if
I have breast implants.
I have clinical symptoms of breast cancer.
I have a history of breast surgery.
I am pregnant or breastfeeding.
I have medical conditions that affect my ability to understand the study.
I am deprived of liberty by judicial or administrative order.
My mammogram images have defects like poor quality or non-standard views.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 par…
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.
Trial Locations
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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 lesion…
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.
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