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Starting soon Not applicable

Role of Artificial Intelligence in Breast Cancer Screening Via Mammography

NCT07882420 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2027-01-31
Last updated
2026-10-20

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
Institut Paoli Calmette Marseille France
Centre Antoine Lacassagne Nice France
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