Back to resultsEvaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images
Primary Purpose
Brain Metastases
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BT-M01
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Metastases
Eligibility Criteria
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
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Positive group
Negative group
Arm Description
A patient diagnosed with brain metastasis after a brain MR
A normal person or a patient not diagnosed with brain metastasis after a brain MR
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Positive predictive values of BT-M01
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
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
Dice coefficient of BT-M01 in detection of brain metastasis based on golden standards
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05573815
Brief Title
Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heuron Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
558 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Positive group
Arm Type
Experimental
Arm Description
A patient diagnosed with brain metastasis after a brain MR
Arm Title
Negative group
Arm Type
Experimental
Arm Description
A normal person or a patient not diagnosed with brain metastasis after a brain MR
Intervention Type
Device
Intervention Name(s)
BT-M01
Intervention Description
Clinical decision support system for detecting brain metastasis
Primary Outcome Measure Information:
Title
Sensitivity and false positive rates of BT-M01
Description
Sensitivity and false positive rates of BT-M01 in detection of brain metastasis based on golden standards
Time Frame
Within 4 weeks after enrollment
Secondary Outcome Measure Information:
Title
Positive predictive values of BT-M01
Description
Positive predictive values of BT-M01 in detection of brain metastasis based on golden standards
Time Frame
Within 4 weeks after enrollment
Title
Sensitivity and Positive predictive values of BT-M01 by primary cancer
Description
Sensitivity and positive predictive values of BT-M01 in detection of brain metastasis based on golden standards by primary cancer
Time Frame
Within 4 weeks after enrollment
Title
Dice coefficient of BT-M01
Description
Dice coefficient of BT-M01 in detection of brain metastasis based on golden standards
Time Frame
Within 4 weeks after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoomi Kim
Phone
+82 032-429-8503
Email
yoomi_kim@iheuron.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Eun Park, M.D.pH.D
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Song-pa Gu
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoomi Kim
Phone
+82 032-429-8507
Email
yoomi_kim@iheuron.com
First Name & Middle Initial & Last Name & Degree
Ji Eun Park, M.D. pH.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images
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