Imaging Features for the Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients who underwent stereotactic radiosurgery (SRS, gamma-knife radiosurgery or cyberknife radiosurgery) for brain metastases. 2. Patients with lesions eligible for SRS :

- One to ten newly diagnosed brain metastases.

- Patients without acute neurological symptom.

3. Patients with a Karnofsky performance status score of 70 or higher. 4. Patients who underwent brain MRI within 1 month of enrollment. 5. Patients with measurable enhancing lesions on MRI. 6. Patients who have available reference standard (second-look surgery for recurrence) or available follow up imaging for clinic-radiologic reference standard. 7. A longest diameter > 1.5 cm for tumor habitat analysis.

Exclusion criteria:

1. Patients who have undergone prior brain surgery, SRS, or whole-brain radiation therapy. 2. Patients who are diagnosed with leukemia, lymphoma, germ-cell tumor, small-cell lung cancer, leptomeningeal disease, or unknown primary tumor. 3. Patients with age < 18 years. 4. Patients without baseline MRI. 5. 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05868928
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Asan Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ho Sung Kim, MD, PhD
Principal Investigator Affiliation	Asan Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases, Radiosurgery

Additional Details

PRIMARY OBJECTIVE:

I. 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:

I. 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.

Arms & Interventions

Arms

: Brain metastases patients who received stereotactic radiosurgery

Patients with brain metastases who received stereotactic radiosurgery

Interventions

Diagnostic Test: - Magnetic resonance imaging (MRI)

Pre-and post-contrast enhanced T1-weighted image, T2-weighted image, fluid-attenuated inversion recovery image

Diagnostic Test: - Diffusion-weighted MRI

Diffusion-weighted MRI

Diagnostic Test: - Arterial spin labeling (ASL)

Cerebral blood flow imaging parameter

Diagnostic Test: - Dynamic susceptibility contrast-MRI (DSC-MRI)

Cerebral blood volume and vessel architectural imaging parameters

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