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Artificial Intelligence in Breast Cancer Screening Programs (AITIC)

M

Maimónides Biomedical Research Institute of Córdoba

Status

Completed

Conditions

Breast Cancer
Screening

Treatments

Diagnostic Test: Mammograms

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

31,301 patients

Sex

Female

Ages

50 to 71 years old

Volunteers

Accepts Healthy Volunteers

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

Exclusion criteria

  1. Women invited to the program who do not agree to participate in the research study by signing the informed consent form.
  2. Women with breast prostheses.
  3. Women with signs or symptoms of suspected breast cancer.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

31,301 participants in 1 patient group

Double reading of all cases with and without Transpara software
Experimental group
Description:
Double reading of all cases with and without Transpara software
Treatment:
Diagnostic Test: Mammograms

Trial contacts and locations

1

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Central trial contact

Esperanza Elias Cabot, MD; Cristina Amate

Data sourced from clinicaltrials.gov

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