Clinical Trials in France / NCT07882420
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Role of Artificial Intelligence in Breast Cancer Screening Via Mammography
NCT07882420 · tracked via the Priya Life Science France tracker
Condition(s) studied
Breast Cancer
Investigational drug(s) / intervention(s)
Transpara software
Transpara software: use of transpara software for breast cancer screening
Study summary
to evaluate the diagnostic performance of radiologists using the Transpara™ Incepto® software to interpret 2D mammograms with tomosynthesis as part of breast cancer screening
Eligibility
Inclusion Criteria:
* A woman referred for a bilateral mammogram as part of individual or organised screening,
* Patient aged 18 or over,
* A patient who has read the information leaflet and signed the informed consent form,
* A patient with health insurance cover.
Exclusion Criteria:
* Patients with a history of breast cancer,
* Patients with a history of breast surgery (cosmetic and/or therapeutic),
* Patients with a history of radiotherapy to the breast,
* Vulnerable populations and participants as defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.
Primary outcome measure(s)
- Sensitivity and specificity (diagnostic performance) of radiologist using the Transpara software — 2 years
Medical conclusion of radiologist using the Transpara software at baseline compared to radiologist's decision alone at 2 years, or the result of the biopsy (positive during the follow-up period or negative at 2 years).
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Institut Paoli Calmette | Marseille | France | |
| Centre Antoine Lacassagne | Nice | France |
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07882420 on ClinicalTrials.gov ↗ ← All trials in France