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

Heuron

Status: Enrolling

Conditions: Brain Metastases

Treatments: Device: BT-M01

Study type: Interventional

Funder types: Industry

Identifiers

NCT05573815

HR-BM-01

Details and patient eligibility

About

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.

Enrollment: 558 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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558 participants in 2 patient groups

Positive group

Experimental group

Description:

A patient diagnosed with brain metastasis after a brain MR

Treatment:

Device: BT-M01

Negative group

Experimental group

Description:

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

Treatment:

Device: BT-M01