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Trial Title:
Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images
NCT ID:
NCT05573815
Condition:
Brain Metastases
Conditions: Official terms:
Neoplasm Metastasis
Brain Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
BT-M01
Description:
Clinical decision support system for detecting brain metastasis
Arm group label:
Negative group
Arm group label:
Positive group
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.
Criteria for 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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Yoomi Kim
Phone:
+82 032-429-8507
Email:
yoomi_kim@iheuron.com
Investigator:
Last name:
Ji Eun Park, M.D. pH.D
Email:
Principal Investigator
Start date:
September 16, 2022
Completion date:
December 31, 2022
Lead sponsor:
Agency:
Heuron Inc.
Agency class:
Industry
Source:
Heuron Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05573815
