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Screening Mammography: Single Reading by One Radiologist With AI vs. Double Reading by Two Radiologists (AI-BCSQ)

NCT07075679 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8000

Last updated 2026-04-02

No results posted yet for this study

Summary

A randomized prospective study comparing the evaluation of mammography images in a breast cancer screening programme by a single radiologist with AI support versus standard double reading by two radiologists without AI support.

Conditions

  • Breast Cancer Screening
  • Artificial Intelligence (AI)
  • Breast Cancer Screening and Diagnosis

Interventions

DIAGNOSTIC_TEST

Group with AI iCAD version 3

Reading mammograms by one radiologist with AI support

DIAGNOSTIC_TEST

Group without AI

Standard double reading by two radiologists without AI.

Sponsors & Collaborators

  • University Hospital Olomouc

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-06
Primary Completion
2028-10-05
Completion
2028-10-05

Countries

  • Czechia

Study Locations

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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 NCT07075679 on ClinicalTrials.gov