Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label, Single-Center and Random-Selection Retrospective Pivotal Study of Clinical Decision Support System for Brain Metastasis Using Brain MR Images

Conditions
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Brain Metastases

Intervention / Treatment
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* Device: BT-M01


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive group<br>A patient diagnosed with brain metastasis after a brain MR | Device: BT-M01<br>* Clinical decision support system for detecting brain metastasis<br>|
| Experimental: Negative group<br>A normal person or a patient not diagnosed with brain metastasis after a brain MR | Device: BT-M01<br>* Clinical decision support system for detecting brain metastasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and false positive rates of BT-M01 | Sensitivity and false positive rates of BT-M01 in detection of brain metastasis based on golden standards | Within 4 weeks after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive values of BT-M01 | Positive predictive values of BT-M01 in detection of brain metastasis based on golden standards | Within 4 weeks after enrollment | 
| Sensitivity and Positive predictive values of BT-M01 by primary cancer | Sensitivity and positive predictive values of BT-M01 in detection of brain metastasis based on golden standards by primary cancer | Within 4 weeks after enrollment | 
| Dice coefficient of BT-M01 | Dice coefficient of BT-M01 in detection of brain metastasis based on golden standards | Within 4 weeks after enrollment |