Artificial Intelligence in Breast Cancer Screening Programs (AITIC)

August 11, 2025 updated by: Maimónides Biomedical Research Institute of Córdoba

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31301

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double reading of all cases with and without Transpara software
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®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Workload of each strategy
Time Frame: In the middle of the study, at 1 year.

The workload of each strategy shall be assessed by multiplying the average time for a reading of that strategy by the total number of readings of that strategy.

The average reading time of a case in each strategy shall be calculated from the measurement of the individual reading time in a sample of 500 cases in each strategy.
In the middle of the study, at 1 year.
Assessment of Workload of each strategy
Time Frame: At the end of the study, at 2 years.

The workload of each strategy shall be assessed by multiplying the average time for a reading of that strategy by the total number of readings of that strategy.

The average reading time of a case in each strategy shall be calculated from the measurement of the individual reading time in a sample of 500 cases in each strategy.
At the end of the study, at 2 years.
Detection rate
Time Frame: In the middle of the study, at 1 year.
Proportion of women diagnosed with breast cancer among those screened.
In the middle of the study, at 1 year.
Detection rate
Time Frame: At the end of the study, at 2 years.
Proportion of women diagnosed with breast cancer among those screened.
At the end of the study, at 2 years.
Recall or referral rate
Time Frame: In the middle of the study, at 1 year.
Proportion of women who, after the screening test, are referred to the breast diagnosis unit.
In the middle of the study, at 1 year.
Recall or referral rate
Time Frame: At the end of the study, at 2 years.
Proportion of women who, after the screening test, are referred to the breast diagnosis unit.
At the end of the study, at 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive predictive value of referrals
Time Frame: In the middle of the study, at 1 year.
Proportion of women diagnosed with breast cancer among those referred to the hospital.
In the middle of the study, at 1 year.
Positive predictive value of referrals
Time Frame: At the end of the study, at 2 years.
Proportion of women diagnosed with breast cancer among those referred to the hospital.
At the end of the study, at 2 years.
Positive predictive value of biopsies
Time Frame: In the middle of the study, at 1 year.
Proportion of women with breast cancer among all women undergoing biopsy.
In the middle of the study, at 1 year.
Positive predictive value of biopsies
Time Frame: At the end of the study, at 2 years.
Proportion of women with breast cancer among all women undergoing biopsy.
At the end of the study, at 2 years.
Positive predictive value of Transpara® scores
Time Frame: In the middle of the study, at 1 year.
Proportion of breast cancers diagnosed among women with a given score.
In the middle of the study, at 1 year.
Positive predictive value of Transpara® scores
Time Frame: At the end of the study, at 2 years.
Proportion of breast cancers diagnosed among women with a given score.
At the end of the study, at 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Investigators

  • Principal Investigator: Esperanza Elias Cabot, MD, Hospital Universitario Reina Sofía de Córdoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

January 11, 2024

Study Completion (Actual)

January 11, 2024

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 30, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AITIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The database and the protocol Will be shared after the trial is published.

IPD Sharing Time Frame

After the trial is published.

IPD Sharing Access Criteria

Upon request to the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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