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OpenTrials
Enrolling by Invitation

NCT Number: NCT06727032

Automated Detection of Brain Metastases on MRI

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.

Enrolling by Invitation

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Netherlands Cancer Institute

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain Metastasis AI

Device

There will be no intervention

Primary outcomes

  1. Detection accuracy

    Time frame: 3 months

    Demonstrate that the accuracy for detecting brain metastases by radiologists on MRI using the software (AIDED) is at least non-inferior to that of radiologists not using the software (UNAIDED).

Secondary outcomes

  1. Reading time

    Time frame: 3 months

    Demonstrate that the AIDED radiologists reading time for detecting brain metastases is significantly lower than for UNAIDED radiologists.

  2. Inter-reader agreement

    Time frame: 3 months

    Demonstrate that AIDED reading reduces detection variation between observers/readers in brain metastasis detection.

Sponsors and collaborators

Lead sponsor

Robovision BV

Industry

Collaborators

  • The Netherlands Cancer Institute

Registry information

Official study title

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

Acronym: BrainMets AI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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