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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05573815

Enrollment

558

Registered

2022-10-10

Start date

2022-09-16

Completion date

2022-12-31

Last updated

2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases

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.

Interventions

DEVICEBT-M01

Clinical decision support system for detecting brain metastasis

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
Dice coefficient of BT-M01	Within 4 weeks after enrollment	Dice coefficient of BT-M01 in detection of brain metastasis based on golden standards

Countries

South Korea

Contacts

Primary ContactYoomi Kim

yoomi_kim@iheuron.com+82 032-429-8503

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026