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

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05573815
• Other study ID #: HR-BM-01
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2022
• Source: Heuron Inc.
• Contact: Yoomi Kim
• Phone: +82 032-429-8503
• Email: yoomi_kim[@]iheuron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 558
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Device:
• BT-M01
Clinical decision support system for detecting brain metastasis

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Song-pa Gu

Sponsors (1)

Lead Sponsor	Collaborator
Heuron Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Dice coefficient of BT-M01	Dice coefficient of BT-M01 in detection of brain metastasis based on golden standards	Within 4 weeks after enrollment