Brain MetastasesNCT05573815
Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images
A study testing BT-M01 in people with Brain Metastases, run by Heuron Inc. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- BT-M01
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Sep 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Song-pa Gu, 05505
Yoomi Kim, +82 032-429-8507, yoomi_kim@iheuron.com
Ji Eun Park, M.D. pH.D
About this study
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
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.
- Conditions
- Brain Metastases
- Being tested
- BT-M01
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT-M01Device
Clinical decision support system for detecting brain metastasis
| Study group | Role | What they receive |
|---|---|---|
| Positive group | Experimental | A patient diagnosed with brain metastasis after a brain MR Receives: Device: BT-M01 |
| Negative group | Experimental | A normal person or a patient not diagnosed with brain metastasis after a brain MR Receives: Device: BT-M01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and false positive rates of BT-M01
Sensitivity and false positive rates of BT-M01 in detection of brain metastasis based on golden standards
Measured: Within 4 weeks after enrollment
Secondary outcomes (3)
Positive predictive values of BT-M01
Positive predictive values of BT-M01 in detection of brain metastasis based on golden standards
Measured: Within 4 weeks after enrollment
Sensitivity and Positive predictive values of BT-M01 by primary cancer
Sensitivity and positive predictive values of BT-M01 in detection of brain metastasis based on golden standards by primary cancer
Measured: Within 4 weeks after enrollment
Dice coefficient of BT-M01
Dice coefficient of BT-M01 in detection of brain metastasis based on golden standards
Measured: Within 4 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start16 Sep 2022
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 558 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heuron Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ji Eun Park, M.D.pH.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573815
- Sponsor's protocol ID
- HR-BM-01
- Status last verified
- Oct 2022
- First submitted
- 6 Oct 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05573815
- Acronym / sponsor ID
- HR-BM-01
- Conditions
- Brain Metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 558 participants (estimated)
- Lead sponsor
- Heuron Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive group | Experimental | Device: BT-M01A patient diagnosed with brain metastasis after a brain MR |
| Negative group | Experimental | Device: BT-M01A normal person or a patient not diagnosed with brain metastasis after a brain MR |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Poor or incomplete brain MR image quality
- A patient with other pathological lesion in brain
- A patients with a history of primary brain tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BT-M01Clinical decision support system for detecting brain metastasis | Device | Negative group, Positive group |
Primary outcome
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
3 secondary outcomes
Positive predictive values of BT-M01
Time frame: Within 4 weeks after enrollment
Sensitivity and Positive predictive values of BT-M01 by primary cancer
Time frame: Within 4 weeks after enrollment
Dice coefficient of BT-M01
Time frame: Within 4 weeks after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Eun Park, M.D.pH.D principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BT-M01 in people with Brain Metastases, run by Heuron Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoomi Kim (+82 032-429-8503, yoomi_kim@iheuron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and false positive rates of BT-M01 (time frame: Within 4 weeks after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.