Brain MetastasesNCT05868928
Imaging Features for the Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis
An observational study of Brain Metastases and Radiosurgery, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This trial uses multi-parametric magnetic resonance imaging (MRI) to develop and validate imaging risk score to predict radiation necrosis in participants with brain metastasis treated with radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Radiosurgery
- What is being tested?
- Magnetic resonance imaging (MRI), Diffusion-weighted MRI and Arterial spin labeling (ASL)
- How many people
- 132 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Dec 2023to 30 Jul 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of tertiary medical center
Who may be able to join
- Patients who underwent stereotactic radiosurgery (SRS, gamma-knife radiosurgery or cyberknife radiosurgery) for brain metastases
- Patients with lesions eligible for SRS :
- One to ten newly diagnosed brain metastases
- Patients without acute neurological symptom
- Patients with a Karnofsky performance status score of 70 or higher
- Patients who underwent brain MRI within 1 month of enrollment
Show all 9Show fewer
- Patients with measurable enhancing lesions on MRI.
- Patients who have available reference standard (second-look surgery for recurrence) or available follow up imaging for clinic-radiologic reference standard.
- A longest diameter > 1.5 cm for tumor habitat analysis.
Who cannot join
- Patients who have undergone prior brain surgery, SRS, or whole-brain radiation therapy.
- Patients who are diagnosed with leukemia, lymphoma, germ-cell tumor, small-cell lung cancer, leptomeningeal disease, or unknown primary tumor.
- Patients with age < 18 years.
- Patients without baseline MRI.
- Patients with nonmeasurable enhancing lesions on MRI : all other lesions, including lesions with longest dimension < 10 mm, lesions with borders that cannot be reproducibly measured, dural metastases, bony skull metastases, and leptomeningeal disease.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
Ho Sung Kim, MD, PhD, +82230105682, radhskim@gmail.com
About this study
Official title: Imaging Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis (IRRAS-BM)
This trial uses multi-parametric magnetic resonance imaging (MRI) to develop and validate imaging risk score to predict radiation necrosis in participants with brain metastasis treated with radiation therapy. Diagnostic procedures, such as multi-parametric magnetic resonance imaging (MRI), may improve the ability to diagnose radiation necrosis early and help establish treatment strategies.
Read the detailed description
PRIMARY OBJECTIVE:
- To develop an imaging risk score for recurrence after stereotactic radiosurgery (SRS) in brain metastasis using multiparametric MRI.
II. To validate the imaging risk score in retrospective external validation and prospective internal validation test set.
SECONDARY OBJECTIVE:
- To predict radiation necrosis using imaging risk score.
OUTLINE:
Participants undergo multi-parametric MRI including 3D pre- and contrast-enhanced T1 weighted image, T2 weighted image, diffusion-weighted image, dynamic susceptibility contrast MRI, and arterial spin labeling image before receiving SRS, and every 3 months after SRS.
- Conditions
- Brain Metastases, Radiosurgery
- Being tested
- Magnetic resonance imaging (MRI), Diffusion-weighted MRI, Arterial spin labeling (ASL), Dynamic susceptibility contrast-MRI (DSC-MRI)
- Keywords
- Imaging, Habitat, Recurrence, Prediction, Radiation necrosis
- Medical subject headings
- Brain Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Diagnostic test
Pre-and post-contrast enhanced T1-weighted image, T2-weighted image, fluid-attenuated inversion recovery image
Diffusion-weighted MRIDiagnostic test
Diffusion-weighted MRI
Arterial spin labeling (ASL)Diagnostic test
Cerebral blood flow imaging parameter
Dynamic susceptibility contrast-MRI (DSC-MRI)Diagnostic test
Cerebral blood volume and vessel architectural imaging parameters
| Study group | Role | What they receive |
|---|---|---|
| Brain metastases patients who received stereotactic radiosurgery | Patients with brain metastases who received stereotactic radiosurgery Receives: Diagnostic Test: Magnetic resonance imaging (MRI); Diagnostic Test: Diffusion-weighted MRI; Diagnostic Test: Arterial spin labeling (ASL); Diagnostic Test: Dynamic susceptibility contrast-MRI (DSC-MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
The time from the date of SRS for brain metastasis until the date of progression.
Measured: up to 24 months
Secondary outcomes (4)
Response rate
The response is determined by response assessment in neuro-oncology brain metastases (RANO-BM) criteria. Clinical and radiologic assessments per lesion and person are carried out at every MRI follow-up using the MRI before SRS as the baseline.
Measured: up to 24 months
Occurence rate of radiation necrosis
The rate of occurrence of radiation necrosis per lesion is determined through a combination of imaging findings and clinical evaluation by a multidisciplinary team.
Measured: 12 months
Imaging risk score for recurrence
To calculate the imaging risk score, three parameters are added together, namely the "solid component score," the "less enhancing component score," and the "blood flow score," using contrast-enhanced T1-weighted image(T1WI), T2-weighted image (T2WI), diffusion-weighted imaging (DWI), and ASL.
The solid component risk score is assigned 0, 1, or 2 points, depending on whether the hypointense lesion on T2WI matches the enhancement in CE-T1WI.
The less-enhancing component risk score evaluates the degree of enhancement of the lesion to the dura. It assigns 0, 1, or 2 points depending on whether it is brighter, similar, or less enhanced.
The blood flow risk score assigns 0, 1, or 2 points based on the degree of blood flow of the lesion in ASL.
Measured: Baseline imaging before SRS, and follow up imaging every 3 months after SRS, up to 24 months
Tumor habitat analysis
Automated process of tumor habitat analysis will include followings.
- Methods: preprocessing includes registration, deep learning segmentation, and normalization of contrast-enhanced T1-weighted (CE-T1) and T2-weighted images. K-means clustering is applied to CE-T1-weighted and T2-weighted images to construct structural MRI habitats and to apparent diffusion coefficient (ADC) and cerebral blood volume (CBV) images to construct physiologic habitats.
- Structural MRI habitats: enhancing tissue habitat, solid low-enhancing habitat, and nonviable tissue habitat
- Physiologic MRI habitats: hypervascular cellular habitat, hypovascular cellular habitat, and nonviable tissue habitat..
- Quantitative measurement of each habitat will be performed.
Measured: Baseline imaging before SRS, and follow up imaging every 3 months after SRS, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start7 Dec 2023
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Sung Kim, Asan Medical Center
- Investigators
- Ho Sung Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868928
- Sponsor's protocol ID
- AsanMCHSKim_07
- Status last verified
- May 2024
- First submitted
- 16 Apr 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Le Rhun E, Guckenberger M, Smits M, Dummer R, Bachelot T, Sahm F, Galldiks N, de Azambuja E, Berghoff AS, Metellus P, Peters S, Hong YK, Winkler F, Schadendorf D, van den Bent M, Seoane J, Stahel R, Minniti G, Wesseling P, Weller M, Preusser M; EANO Executive Board and ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. EANO-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up of patients with brain metastasis from solid tumours. Ann Oncol. 2021 Nov;32(11):1332-1347. doi: 10.1016/j.annonc.2021.07.016. Epub 2021 Aug 6. No abstract available.
PubMed 34364998Chao ST, Ahluwalia MS, Barnett GH, Stevens GH, Murphy ES, Stockham AL, Shiue K, Suh JH. Challenges with the diagnosis and treatment of cerebral radiation necrosis. Int J Radiat Oncol Biol Phys. 2013 Nov 1;87(3):449-57. doi: 10.1016/j.ijrobp.2013.05.015. Epub 2013 Jun 19.
PubMed 23790775Jhaveri J, Chowdhary M, Zhang X, Press RH, Switchenko JM, Ferris MJ, Morgan TM, Roper J, Dhabaan A, Elder E, Eaton BR, Olson JJ, Curran WJ, Shu HG, Crocker IR, Patel KR. Does size matter? Investigating the optimal planning target volume margin for postoperative stereotactic radiosurgery to resected brain metastases. J Neurosurg. 2019 Mar 1;130(3):797-803. doi: 10.3171/2017.9.JNS171735. Epub 2018 Apr 20.
PubMed 29676690Kirkpatrick JP, Wang Z, Sampson JH, McSherry F, Herndon JE 2nd, Allen KJ, Duffy E, Hoang JK, Chang Z, Yoo DS, Kelsey CR, Yin FF. Defining the optimal planning target volume in image-guided stereotactic radiosurgery of brain metastases: results of a randomized trial. Int J Radiat Oncol Biol Phys. 2015 Jan 1;91(1):100-8. doi: 10.1016/j.ijrobp.2014.09.004. Epub 2014 Oct 21.
PubMed 25442342Lin NU, Lee EQ, Aoyama H, Barani IJ, Barboriak DP, Baumert BG, Bendszus M, Brown PD, Camidge DR, Chang SM, Dancey J, de Vries EG, Gaspar LE, Harris GJ, Hodi FS, Kalkanis SN, Linskey ME, Macdonald DR, Margolin K, Mehta MP, Schiff D, Soffietti R, Suh JH, van den Bent MJ, Vogelbaum MA, Wen PY; Response Assessment in Neuro-Oncology (RANO) group. Response assessment criteria for brain metastases: proposal from the RANO group. Lancet Oncol. 2015 Jun;16(6):e270-8. doi: 10.1016/S1470-2045(15)70057-4. Epub 2015 May 27.
PubMed 26065612Stockham AL, Tievsky AL, Koyfman SA, Reddy CA, Suh JH, Vogelbaum MA, Barnett GH, Chao ST. Conventional MRI does not reliably distinguish radiation necrosis from tumor recurrence after stereotactic radiosurgery. J Neurooncol. 2012 Aug;109(1):149-58. doi: 10.1007/s11060-012-0881-9. Epub 2012 May 26.
PubMed 22638727Tsao MN, Rades D, Wirth A, Lo SS, Danielson BL, Gaspar LE, Sperduto PW, Vogelbaum MA, Radawski JD, Wang JZ, Gillin MT, Mohideen N, Hahn CA, Chang EL. Radiotherapeutic and surgical management for newly diagnosed brain metastasis(es): An American Society for Radiation Oncology evidence-based guideline. Pract Radiat Oncol. 2012 Jul-Sep;2(3):210-225. doi: 10.1016/j.prro.2011.12.004. Epub 2012 Jan 30.
PubMed 25925626Lee DH, Park JE, Kim N, Park SY, Kim YH, Cho YH, Kim HS. Tumor habitat analysis by magnetic resonance imaging distinguishes tumor progression from radiation necrosis in brain metastases after stereotactic radiosurgery. Eur Radiol. 2022 Jan;32(1):497-507. doi: 10.1007/s00330-021-08204-1. Epub 2021 Aug 6.
PubMed 34357451Park JE, Kim HS, Kim N, Park SY, Kim YH, Kim JH. Spatiotemporal Heterogeneity in Multiparametric Physiologic MRI Is Associated with Patient Outcomes in IDH-Wildtype Glioblastoma. Clin Cancer Res. 2021 Jan 1;27(1):237-245. doi: 10.1158/1078-0432.CCR-20-2156. Epub 2020 Oct 7.
PubMed 33028594Sneed PK, Mendez J, Vemer-van den Hoek JG, Seymour ZA, Ma L, Molinaro AM, Fogh SE, Nakamura JL, McDermott MW. Adverse radiation effect after stereotactic radiosurgery for brain metastases: incidence, time course, and risk factors. J Neurosurg. 2015 Aug;123(2):373-86. doi: 10.3171/2014.10.JNS141610. Epub 2015 May 15.
PubMed 25978710Roh YH, Park JE, Park SY, Cho YH, Kim YH, Song SW, Yoon S, Kim HS. Assessment of imaging risks for recurrence after stereotactic radiosurgery for brain metastases (IRRaS-BM). BMC Cancer. 2024 Jul 18;24(1):866. doi: 10.1186/s12885-024-12636-5.
PubMed 39026289
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis (IRRAS-BM)
- ClinicalTrials.gov ID
- NCT05868928
- Acronym / sponsor ID
- AsanMCHSKim_07
- Conditions
- Brain Metastases, Radiosurgery
- Keywords
- Imaging, Habitat, Recurrence, Prediction, Radiation necrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 22 May 2023 (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.
This trial uses multi-parametric magnetic resonance imaging (MRI) to develop and validate imaging risk score to predict radiation necrosis in participants with brain metastasis treated with radiation therapy. Diagnostic procedures, such as multi-parametric magnetic resonance imaging (MRI), may improve the ability to diagnose radiation necrosis early and help establish treatment strategies.
Detailed description
PRIMARY OBJECTIVE:
- To develop an imaging risk score for recurrence after stereotactic radiosurgery (SRS) in brain metastasis using multiparametric MRI.
II. To validate the imaging risk score in retrospective external validation and prospective internal validation test set.
SECONDARY OBJECTIVE:
- To predict radiation necrosis using imaging risk score.
OUTLINE:
Participants undergo multi-parametric MRI including 3D pre- and contrast-enhanced T1 weighted image, T2 weighted image, diffusion-weighted image, dynamic susceptibility contrast MRI, and arterial spin labeling image before receiving SRS, and every 3 months after SRS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain metastases patients who received stereotactic radiosurgery | – | Diagnostic Test: Magnetic resonance imaging (MRI), Diagnostic Test: Diffusion-weighted MRI, Diagnostic Test: Arterial spin labeling (ASL), Diagnostic Test: Dynamic susceptibility contrast-MRI (DSC-MRI)Patients with brain metastases who received stereotactic radiosurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of tertiary medical center
Key inclusion criteria (9 listed)
- Patients who underwent stereotactic radiosurgery (SRS, gamma-knife radiosurgery or cyberknife radiosurgery) for brain metastases
- Patients with lesions eligible for SRS :
- Patients with a Karnofsky performance status score of 70 or higher
- Patients who underwent brain MRI within 1 month of enrollment
- Patients with measurable enhancing lesions on MRI.
Key exclusion criteria (5 listed)
- Patients who have undergone prior brain surgery, SRS, or whole-brain radiation therapy.
- Patients who are diagnosed with leukemia, lymphoma, germ-cell tumor, small-cell lung cancer, leptomeningeal disease, or unknown primary tumor.
- Patients with age < 18 years.
- Patients without baseline MRI.
- Patients with nonmeasurable enhancing lesions on MRI : all other lesions, including lesions with longest dimension < 10 mm, lesions with borders that cannot be reproducibly measured, dural metastases, bony skull metastases, and leptomeningeal disease.
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 |
|---|---|---|
| Magnetic resonance imaging (MRI)Pre-and post-contrast enhanced T1-weighted image, T2-weighted image, fluid-attenuated inversion recovery image | Diagnostic test | Brain metastases patients who received stereotactic radiosurgery |
| Diffusion-weighted MRIDiffusion-weighted MRI | Diagnostic test | Brain metastases patients who received stereotactic radiosurgery |
| Arterial spin labeling (ASL)Cerebral blood flow imaging parameter | Diagnostic test | Brain metastases patients who received stereotactic radiosurgery |
| Dynamic susceptibility contrast-MRI (DSC-MRI)Cerebral blood volume and vessel architectural imaging parameters | Diagnostic test | Brain metastases patients who received stereotactic radiosurgery |
Primary outcome
Time to progression
Time frame: up to 24 months
The time from the date of SRS for brain metastasis until the date of progression.
4 secondary outcomes
Response rate
Time frame: up to 24 months
Occurence rate of radiation necrosis
Time frame: 12 months
Imaging risk score for recurrence
Time frame: Baseline imaging before SRS, and follow up imaging every 3 months after SRS, up to 24 months
Tumor habitat analysis
Time frame: Baseline imaging before SRS, and follow up imaging every 3 months after SRS, up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 34364998Le Rhun E, Guckenberger M, Smits M, Dummer R, Bachelot T, Sahm F, Galldiks N, de Azambuja E, Berghoff AS, Metellus P, Peters S, Hong YK, Winkler F, Schadendorf D, van den Bent M, Seoane J, Stahel R, Minniti G, Wesseling P, Weller M, Preusser M; EANO Executive Board and ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. EANO-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up of patients with brain metastasis from solid tumours. Ann Oncol. 2021 Nov;32(11):1332-1347. doi: 10.1016/j.annonc.2021.07.016. Epub 2021 Aug 6. No abstract available.
- Background: PubMed 23790775Chao ST, Ahluwalia MS, Barnett GH, Stevens GH, Murphy ES, Stockham AL, Shiue K, Suh JH. Challenges with the diagnosis and treatment of cerebral radiation necrosis. Int J Radiat Oncol Biol Phys. 2013 Nov 1;87(3):449-57. doi: 10.1016/j.ijrobp.2013.05.015. Epub 2013 Jun 19.
- Background: PubMed 29676690Jhaveri J, Chowdhary M, Zhang X, Press RH, Switchenko JM, Ferris MJ, Morgan TM, Roper J, Dhabaan A, Elder E, Eaton BR, Olson JJ, Curran WJ, Shu HG, Crocker IR, Patel KR. Does size matter? Investigating the optimal planning target volume margin for postoperative stereotactic radiosurgery to resected brain metastases. J Neurosurg. 2019 Mar 1;130(3):797-803. doi: 10.3171/2017.9.JNS171735. Epub 2018 Apr 20.
- Background: PubMed 25442342Kirkpatrick JP, Wang Z, Sampson JH, McSherry F, Herndon JE 2nd, Allen KJ, Duffy E, Hoang JK, Chang Z, Yoo DS, Kelsey CR, Yin FF. Defining the optimal planning target volume in image-guided stereotactic radiosurgery of brain metastases: results of a randomized trial. Int J Radiat Oncol Biol Phys. 2015 Jan 1;91(1):100-8. doi: 10.1016/j.ijrobp.2014.09.004. Epub 2014 Oct 21.
- Background: PubMed 26065612Lin NU, Lee EQ, Aoyama H, Barani IJ, Barboriak DP, Baumert BG, Bendszus M, Brown PD, Camidge DR, Chang SM, Dancey J, de Vries EG, Gaspar LE, Harris GJ, Hodi FS, Kalkanis SN, Linskey ME, Macdonald DR, Margolin K, Mehta MP, Schiff D, Soffietti R, Suh JH, van den Bent MJ, Vogelbaum MA, Wen PY; Response Assessment in Neuro-Oncology (RANO) group. Response assessment criteria for brain metastases: proposal from the RANO group. Lancet Oncol. 2015 Jun;16(6):e270-8. doi: 10.1016/S1470-2045(15)70057-4. Epub 2015 May 27.
- Background: PubMed 22638727Stockham AL, Tievsky AL, Koyfman SA, Reddy CA, Suh JH, Vogelbaum MA, Barnett GH, Chao ST. Conventional MRI does not reliably distinguish radiation necrosis from tumor recurrence after stereotactic radiosurgery. J Neurooncol. 2012 Aug;109(1):149-58. doi: 10.1007/s11060-012-0881-9. Epub 2012 May 26.
- Background: PubMed 25925626Tsao MN, Rades D, Wirth A, Lo SS, Danielson BL, Gaspar LE, Sperduto PW, Vogelbaum MA, Radawski JD, Wang JZ, Gillin MT, Mohideen N, Hahn CA, Chang EL. Radiotherapeutic and surgical management for newly diagnosed brain metastasis(es): An American Society for Radiation Oncology evidence-based guideline. Pract Radiat Oncol. 2012 Jul-Sep;2(3):210-225. doi: 10.1016/j.prro.2011.12.004. Epub 2012 Jan 30.
- Background: PubMed 34357451Lee DH, Park JE, Kim N, Park SY, Kim YH, Cho YH, Kim HS. Tumor habitat analysis by magnetic resonance imaging distinguishes tumor progression from radiation necrosis in brain metastases after stereotactic radiosurgery. Eur Radiol. 2022 Jan;32(1):497-507. doi: 10.1007/s00330-021-08204-1. Epub 2021 Aug 6.
- Background: PubMed 33028594Park JE, Kim HS, Kim N, Park SY, Kim YH, Kim JH. Spatiotemporal Heterogeneity in Multiparametric Physiologic MRI Is Associated with Patient Outcomes in IDH-Wildtype Glioblastoma. Clin Cancer Res. 2021 Jan 1;27(1):237-245. doi: 10.1158/1078-0432.CCR-20-2156. Epub 2020 Oct 7.
- Background: PubMed 25978710Sneed PK, Mendez J, Vemer-van den Hoek JG, Seymour ZA, Ma L, Molinaro AM, Fogh SE, Nakamura JL, McDermott MW. Adverse radiation effect after stereotactic radiosurgery for brain metastases: incidence, time course, and risk factors. J Neurosurg. 2015 Aug;123(2):373-86. doi: 10.3171/2014.10.JNS141610. Epub 2015 May 15.
- Derived from this study: PubMed 39026289Roh YH, Park JE, Park SY, Cho YH, Kim YH, Song SW, Yoon S, Kim HS. Assessment of imaging risks for recurrence after stereotactic radiosurgery for brain metastases (IRRaS-BM). BMC Cancer. 2024 Jul 18;24(1):866. doi: 10.1186/s12885-024-12636-5.
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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.
Ho Sung Kim, MD, PhD 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?
An observational study of Brain Metastases and Radiosurgery, run by Asan Medical Center 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 9 inclusion and 5 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 14 May 2024. 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 Ho Sung Kim, MD, PhD (+82230105682, radhskim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05868928, which also lists 11 linked publications.
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 14 May 2024.