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

October 6, 2022 updated by: Heuron Inc.

An Open Label, Single-Center and Random-Selection Retrospective Pivotal Study of Clinical Decision Support System for Brain Metastasis Using Brain MR Images

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

558

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Song-pa Gu
      • Seoul, Song-pa Gu, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Ji Eun Park, M.D. pH.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and false positive rates of BT-M01
Time Frame: Within 4 weeks after enrollment
Sensitivity and false positive rates of BT-M01 in detection of brain metastasis based on golden standards
Within 4 weeks after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive predictive values of BT-M01
Time Frame: Within 4 weeks after enrollment
Positive predictive values of BT-M01 in detection of brain metastasis based on golden standards
Within 4 weeks after enrollment
Sensitivity and Positive predictive values of BT-M01 by primary cancer
Time Frame: 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
Within 4 weeks after enrollment
Dice coefficient of BT-M01
Time Frame: Within 4 weeks after enrollment
Dice coefficient of BT-M01 in detection of brain metastasis based on golden standards
Within 4 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heuron Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2022

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-BM-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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