Artificial Intelligence in Breast Cancer Screening Programs

Last updated: August 11, 2025
Sponsor: Maimónides Biomedical Research Institute of Córdoba
Overall Status: Completed

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Mammograms

Clinical Study ID

NCT04949776
AITIC
  • Ages 50-71
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

All women between 50 and 71 years of age (including women who reach that age in the year of appointment), in the Reina Sofía University Hospital district, invited to participate in the Breast Cancer Early Detection Program, that have been randomly assigned in the Hologic equipment (DM or DBT), and who agree to participate in the study by signing the informed consent form.

  1. Women studied in the program during the established period and who have previouslyparticipated.

  2. Women studied in the program for the first time in the established period.

Exclusion

Exclusion Criteria:

  1. Women invited to the program who do not agree to participate in the research studyby signing the informed consent form.

  2. Women with breast prostheses.

  3. Women with signs or symptoms of suspected breast cancer.

Study Design

Total Participants: 31301
Treatment Group(s): 1
Primary Treatment: Mammograms
Phase:
Study Start date:
March 15, 2022
Estimated Completion Date:
January 11, 2024

Connect with a study center

  • Hospital Universitario Reina Sofia

    Córdoba, 14004
    Spain

    Site Not Available

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