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

Not Applicable

Recruiting

• Conditions: Brain Metastases
• Interventions: Device: BT-M01

• Registration Number: NCT05573815
• Lead Sponsor: Heuron Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-16
• Status Verified: 2022-10
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-06
• Last Update Submitted: 2022-10-06
• Study First Posted: 2022-10-10
• Last Update Posted: 2022-10-10
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 558

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative group	BT-M01	A normal person or a patient not diagnosed with brain metastasis after a brain MR
Positive group	BT-M01	A patient diagnosed with brain metastasis after a brain MR

Primary Outcome Measures

Name	Time	Method
Sensitivity and false positive rates of BT-M01	Within 4 weeks after enrollment	Sensitivity and false positive rates of BT-M01 in detection of brain metastasis based on golden standards

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Song-pa Gu, Korea, Republic of