Health TrialsbyHealthPanel

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

ConditionsBreast Cancer ScreeningArtificial Intelligence (AI)Breast Cancer Screening and Diagnosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-69
SponsorUniversity Hospital Olomouc

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age 45-69, asymptomatic woman participating in breast cancer screening programme

Disqualifiers

clinical signs of breast disease - indication for diagnostic mammography

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group with AI iCAD version 3

    Diagnostic test

    Reading mammograms by one radiologist with AI support

  • Group without AI

    Diagnostic test

    Standard double reading by two radiologists without AI.

Treatment groups

8,000 Participants
are divided into 2 treatment groups
Group A: Group with AIExperimental treatment 1 intervention
Group B: Group without AIOther 1 intervention

Trial outcomes

Primary outcomes

1

Further assessment rate

The proportion of women udergoing follow-up examinations within 0-190 days after screening mammography.

Time frame
up to 190 days after screening mammmography

Secondary outcomes

1

Cancer Detection Rate

The number of cancers detected per 1,000 women screened.

Time frame
up to 1 year after screening mammography
2

Recall Rate

The proportion of women recalled for follow-up examinations withing 1-190 days after screening mammography.

Time frame
up to 190 days after screening mammography

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Olomouc

Lead sponsor

Source ClinicalTrials.gov
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