Clinical Trials Directory

Trials / Enrolling By Invitation

Enrolling By InvitationNCT06727032

Automated Detection of Brain Metastases on MRI

Validation of an AI Software for Detection of Brain Metastases on MRI: AIDED Versus UNAIDED Performance

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
12 (estimated)
Sponsor
Robovision BV · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEBrain Metastasis AIThere will be no intervention

Timeline

Start date
2025-01-24
Primary completion
2025-09-01
Completion
2025-10-01
First posted
2024-12-10
Last updated
2025-08-03

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT06727032. Inclusion in this directory is not an endorsement.