NCT04949776

Artificial Intelligence in Breast Cancer Screening Programs

New Strategies Based on Artificial Intelligence in Breast Cancer Screening Programs in Córdoba With Digital Mammography and Digital Breast Tomosynthesis. A Prospective Evaluation.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31,301 (actual)
• Sponsor: Maimónides Biomedical Research Institute of Córdoba · Academic / Other
• Sex: Female
• Age: 50 Years – 71 Years
• Healthy volunteers: Accepted

Summary

The use of artificial intelligence software in breast screening (Transpara®) makes it possible to identify studies with a very low probability of cancer. The hypothesis raised in this work is that reading strategies based on artificial intelligence (single or double reading only of cases with a score\> 7 with Transpara®), allow reducing the workload of a screening program by more than 50 % with respect to the standard reading of the program (double reading of all cases without Transpara®), without presenting inferiority in terms of detection rates and recalls of the program, both with the use of 2D digital mammography and with the use of tomosynthesis or 3D mammogram.

Conditions

• Breast Cancer
• Screening

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Mammograms	In the women participating in the study, two strategies for reading mammograms will be carried out: Strategy 1: Standard reading of the program. Double independent and non-consensual reading of all cases, without any artificial intelligence system (standard strategy). Strategy 2: Reading strategy based on the global Score granted by Transpara® (strategy based on artificial intelligence): * In studies with a Score \<8 (studies with a low probability of cancer): They will not be evaluated by any radiologist. * In studies with a Score\> 7 (studies with a high probability of cancer): double reading will be carried out, assisted by Transpara®.

Timeline

• Start date: 2022-03-15
• Primary completion: 2024-01-11
• Completion: 2024-01-11
• First posted: 2021-07-02
• Last updated: 2025-08-14

Locations

1 site across 1 country: Spain