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Artificial Intelligence in Breast Cancer Screening Programs

NCT04949776 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31301

Last updated 2025-08-14

No results posted yet for this 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.

Conditions

Interventions

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®.

Sponsors & Collaborators

  • Maimónides Biomedical Research Institute of Córdoba

    lead OTHER

Principal Investigators

  • Esperanza Elias Cabot, MD · Hospital Universitario Reina Sofia de Cordoba

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
71 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2024-01-11
Completion
2024-01-11

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04949776 on ClinicalTrials.gov