Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images
An Open Label, Single-Center and Random-Selection Retrospective Pivotal Study of Clinical Decision Support System for Brain Metastasis Using Brain MR Images
1 other identifier
interventional
558
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 16, 2022
CompletedFirst Submitted
Initial submission to the registry
October 6, 2022
CompletedFirst Posted
Study publicly available on registry
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedOctober 10, 2022
October 1, 2022
3 months
October 6, 2022
October 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Positive predictive values of BT-M01
Within 4 weeks after enrollment
Sensitivity and Positive predictive values of BT-M01 by primary cancer
Within 4 weeks after enrollment
Dice coefficient of BT-M01
Within 4 weeks after enrollment
Study Arms (2)
Positive group
EXPERIMENTALA patient diagnosed with brain metastasis after a brain MR
Negative group
EXPERIMENTALA normal person or a patient not diagnosed with brain metastasis after a brain MR
Interventions
Clinical decision support system for detecting brain metastasis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Poor or incomplete brain MR image quality
- A patient with other pathological lesion in brain
- A patients with a history of primary brain tumors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heuron Inc.lead
Study Sites (1)
Asan Medical Center
Seoul, Song-pa Gu, 05505, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji Eun Park, M.D.pH.D
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2022
First Posted
October 10, 2022
Study Start
September 16, 2022
Primary Completion
November 30, 2022
Study Completion
December 31, 2022
Last Updated
October 10, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share