Clinical trial · Observational
Automated Detection of Brain Metastases on MRI
Validation of an AI Software for Detection of Brain Metastases on MRI: AIDED Versus UNAIDED Performance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brain Metastasis AI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Detection accuracy
- timeFrame
- 3 months
- description
- 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 (2)
- measure
- Reading time
- timeFrame
- 3 months
- description
- Demonstrate that the AIDED radiologists reading time for detecting brain metastases is significantly lower than for UNAIDED radiologists.
- measure
- Inter-reader agreement
- timeFrame
- 3 months
- description
- Demonstrate that AIDED reading reduces detection variation between observers/readers in brain metastasis detection.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available