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Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI

NCT05800132 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2024-04-12

No results posted yet for this study

Summary

The goal of this clinical trial is to compare, for the second reading of screening mammograms, the standard of care with an AI assisted scenario.

The main questions it aims to answer are:

* will the experimental pathway be non-inferior to the standard pathway?
* will the experimental pathway be economically superior to the standard pathway?

Participants will receive screening mammograms, as part of the breast cancer screening program. Researchers will compare the interpretation made by the second reader in the standard pathway with the AI assisted interpretation made by a different reader in the experimental pathway.

Conditions

Interventions

DEVICE

MammoScreen

Diagnostic reading aid for breast cancer screening

Sponsors & Collaborators

  • Therapixel

    lead INDUSTRY

Principal Investigators

  • Brigitte Seradour · Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Région Sud PACA

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-08-31
Completion
2027-09-30

Countries

  • France

Study Locations

More Related Trials

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 NCT05800132 on ClinicalTrials.gov