RECRUITINGOBSERVATIONAL
Imaging Features for the Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis
Imaging Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis (IRRAS-BM)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
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
Locations (1)
Asan Medical Center
Seoul, South Korea