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New treatment option for Breast Cancer
Official title Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
ClinicalTrials.gov ID: NCT05800132
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 74, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Having expressed her willingness to participate in the study, to undergo all the procedures and to make herself available for the expected duration...
- Having completed and signed the informed consent form.
You likely can't join if
- 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,
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aubagne, France
- Draguignan, France
- Fréjus, France
- Marseille, France
- Saint-Raphaël, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 50 years to 74 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aubagne, France; Draguignan, France; Fréjus, France; Marseille, France; Saint-Raphaël, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.