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

NCT ID: NCT05573815

Last Updated: 2022-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

558 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-16

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Brain Metastases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Positive group

A patient diagnosed with brain metastasis after a brain MR

Group Type EXPERIMENTAL

BT-M01

Intervention Type DEVICE

Clinical decision support system for detecting brain metastasis

Negative group

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

Group Type EXPERIMENTAL

BT-M01

Intervention Type DEVICE

Clinical decision support system for detecting brain metastasis

Interventions

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BT-M01

Clinical decision support system for detecting brain metastasis

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heuron Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ji Eun Park, M.D.pH.D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, Song-pa Gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yoomi Kim

Role: CONTACT

+82 032-429-8503

Facility Contacts

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Yoomi Kim

Role: primary

+82 032-429-8507

Other Identifiers

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HR-BM-01

Identifier Type: -

Identifier Source: org_study_id

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