Automated Detection of Brain Metastases on MRI (BrainMets AI)

Robovision BV

Status: Invitation-only

Conditions: Brain Metastases

Treatments: Device: Brain Metastasis AI

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06727032

CI-2024-BrainMetsAI

IRBd20-090 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects older than 18 years with a known or possible primary extracranial cancer who undergo MRI for diagnosis, treatment planning or follow-up of brain metastases.

Exclusion criteria

• subjects with primary intracranial tumor(s), with more than 10 brain metastases, with meningeal metastases, with radiation necrosis, or post brain surgery