Automated Detection of Brain Metastases on MRI

Sponsor
Robovision BV
Study ID
NCT06727032
Status
Enrolling By Invitation

Conditions

  • Brain Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brain Metastasis AI — DEVICE
    There will be no intervention

Study Details

This reader study aims at assessing whether the radiologist aided with AI software has at least a non-inferior performance than without AI assistance in detecting brain metastases. 200 retrospective MRI images will be included in the study with 100 positive and 100 negative exams. Assessment will be completed by 12 readers with varying level of experience. This is a Retrospective Multiple-Reader Multiple-Case (MRMC) randomised study.

Key Dates

First listed
Dec 10, 2024
Start date
Jan 24, 2025
Status verified
Aug 2025
Primary completion
Sep 30, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
12 participants (estimated)

Primary Outcome Measure

Detection accuracy [ Time Frame: 3 months ]

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