Comparing AI-assisted and standard second readings of breast cancer screening mammograms
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
This study is testing if using AI to help read breast cancer screening mammograms is just as good as having a radiologist do it alone, to see if it can improve accuracy and save money.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5000 (estimated) |
| Ages | 50 Years to 74 Years |
| Sex | Female |
| Sponsor | Therapixel Industry-sponsored |
| Locations | 7 sites (Aubagne and 6 other locations) |
| Trial ID | NCT05800132 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the diagnostic performance of an AI-assisted second reading process for breast cancer screening mammograms compared to the standard second reading by a radiologist. Participants will undergo screening mammograms, and their images will be interpreted in two ways: first by AI and then by a radiologist if the AI flags any concerns. The study will assess whether the AI-assisted approach is non-inferior to the traditional method in terms of diagnostic accuracy and whether it offers economic advantages. The final decision on mammogram results will be based on the most conservative assessment from both readings.
Who should consider this trial
Good fit: Ideal candidates are women affiliated with the French social security system who have normal or benign mammogram results and are willing to participate.
Not a fit: Patients with breast implants, clinical symptoms of breast cancer, or a history of breast surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and efficiency of breast cancer screenings, potentially leading to earlier detection and better patient outcomes.
How similar studies have performed: Other studies have shown promising results with AI-assisted diagnostic processes in medical imaging, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aubagne and 6 other locations
- Centre de radiologie Les Défensions — Aubagne, France (Recruiting)
- Var Imagerie Medicale — Draguignan, France (Recruiting)
- VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper — Fréjus, France (Recruiting)
- VAR IMAGERIE MEDICALE - Clinique Les Lauriers — Fréjus, France (Recruiting)
- Cabinet de Radiologie du Cabot — Marseille, France (Completed)
- Centre de Sénologie Mermoz — Marseille, France (Recruiting)
- VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon — Saint-Raphaël, France (Recruiting)
Study contacts
- Principal investigator: Brigitte Seradour — Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Région Sud PACA
- Study coordinator: Brigitte Seradour
- Email: brigitteseradour@hotmail.fr
- Phone: 06 09 88 38 64
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.