Clinical trial · Interventional
Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images
An Open Label, Single-Center and Random-Selection Retrospective Pivotal Study of Clinical Decision Support System for Brain Metastasis Using Brain MR Images
- 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)
BT-M01 is a software that has been pre-learned based on a brain metastasis detection model using brain MR images, and clinical decision support system for brain metastasis by automatically analyzing brain MR images by assisting the medical team. The specific aims of this study are to evaluate efficacy of BT-M01 for brain metastasis compared to the sensitivity and false positive rates of radiologists group.
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 |
|---|---|---|---|
| BT-M01 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Positive group
- description
- A patient diagnosed with brain metastasis after a brain MR
- interventionNames
- Device: BT-M01
- type
- EXPERIMENTAL
- label
- Negative group
- description
- A normal person or a patient not diagnosed with brain metastasis after a brain MR
- interventionNames
- Device: BT-M01
Primary outcomes (1)
- measure
- Sensitivity and false positive rates of BT-M01
- timeFrame
- Within 4 weeks after enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Adults over 19 years old * Brain MR acquired * Positive group: A patient diagnosed with brain metastasis after a brain MR * Negative group: A normal person or a patient not diagnosed with brain metastasis after a brain MR Exclusion Criteria: * Poor or incomplete brain MR image quality * A patient with other pathological lesion in brain * A patients with a history of primary brain tumors
References
Publications (0)
Data not yet available