MedPath

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

Not Applicable
Recruiting
Conditions
Brain Metastases
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

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
Primary Outcome Measures
NameTimeMethod
Sensitivity and false positive rates of BT-M01Within 4 weeks after enrollment

Sensitivity and false positive rates of BT-M01 in detection of brain metastasis based on golden standards

Secondary Outcome Measures
NameTimeMethod
Positive predictive values of BT-M01Within 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 cancerWithin 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-M01Within 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

Asan Medical Center
🇰🇷Seoul, Song-pa Gu, Korea, Republic of
Yoomi Kim
Contact
+82 032-429-8507
yoomi_kim@iheuron.com
Ji Eun Park, M.D. pH.D
Principal Investigator

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