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Enrolling by invitation NCT06727032

Automated Detection of Brain Metastases on MRI

— Observational Brain Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brain Metastasis AI.
Who it may be relevant to
Registry conditions: Brain Metastases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Brain Metastasis AI
    There will be no intervention

Primary outcome measures

  • Detection accuracy [Time frame: 3 months]
Secondary outcome measures (2)
  • Reading time [Time frame: 3 months]
  • Inter-reader agreement [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Netherlands · 1 center
  • Netherlands Cancer Institute — Amsterdam

Identifiers

NCT: NCT06727032 · CI-2024-BrainMetsAI · IRBd20-090

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗