Skip to main content
OpenTrials
Completed

NCT Number: NCT04949776

Artificial Intelligence in Breast Cancer Screening Programs

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Screening Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year–71 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

  • Women studied in the program during the established period and who have previously participated.
  • Women studied in the program for the first time in the established period.

Exclusion criteria

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

Treatment and study plan

Mammograms

Diagnostic Test

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®.

Primary outcomes

  1. 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.

  2. 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.

  3. Detection rate

    Time frame: In the middle of the study, at 1 year.

    Proportion of women diagnosed with breast cancer among those screened.

  4. Detection rate

    Time frame: At the end of the study, at 2 years.

    Proportion of women diagnosed with breast cancer among those screened.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Registry information

Official study title

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

Acronym: AITIC

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 2, 2021
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.