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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive group | Experimental | A patient diagnosed with brain metastasis after a brain MR |
|
| Negative group | Experimental | A normal person or a patient not diagnosed with brain metastasis after a brain MR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT-M01 | Device | Clinical decision support system for detecting brain metastasis |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoomi Kim | Contact | +82 032-429-8503 | yoomi_kim@iheuron.com |
| Name | Affiliation | Role |
|---|---|---|
| Ji Eun Park, M.D.pH.D | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | Song-pa Gu | 05505 | South Korea |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |