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

Sponsor
Heuron Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05573815
Collaborator
(none)
558
Enrollment
1
Location
2
Arms
3.5
Anticipated Duration (Months)
160.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: BT-M01
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
558 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Sep 16, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Positive group

A patient diagnosed with brain metastasis after a brain MR

Device: BT-M01
Clinical decision support system for detecting brain metastasis
Experimental: Negative group

A normal person or a patient not diagnosed with brain metastasis after a brain MR

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

Outcome Measures

Primary Outcome Measures

  1. Sensitivity and false positive rates of BT-M01 [Within 4 weeks after enrollment]

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

Secondary Outcome Measures

  1. Positive predictive values of BT-M01 [Within 4 weeks after enrollment]

    Positive predictive values of BT-M01 in detection of brain metastasis based on golden standards

  2. Sensitivity and Positive predictive values of BT-M01 by primary cancer [Within 4 weeks after enrollment]

    Sensitivity and positive predictive values of BT-M01 in detection of brain metastasis based on golden standards by primary cancer

  3. Dice coefficient of BT-M01 [Within 4 weeks after enrollment]

    Dice coefficient of BT-M01 in detection of brain metastasis based on golden standards

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan Medical Center Seoul Song-pa Gu Korea, Republic of 05505

Sponsors and Collaborators

  • Heuron Inc.

Investigators

  • Principal Investigator: Ji Eun Park, M.D.pH.D, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heuron Inc.
ClinicalTrials.gov Identifier:
NCT05573815
Other Study ID Numbers:
  • HR-BM-01
First Posted:
Oct 10, 2022
Last Update Posted:
Oct 10, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms

Study Results

No Results Posted as of Oct 10, 2022