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NCT05868928 | RECRUITING | Brain Metastases

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

Asan Medical Center

Information provided by (Responsible Party):

Ho sung kim

Brief 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. Diagnostic procedures, such as multi-parametric magnetic resonance imaging (MRI), may improve the ability to diagnose radiation necrosis early and help establish treatment strategies.

Condition or disease

Brain Metastases

Radiosurgery

Intervention/treatment

Magnetic resonance imaging (MRI)

Diffusion-weighted MRI

Arterial spin labeling (ASL)

Dynamic susceptibility contrast-MRI (DSC-MRI)

Detailed Description:

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 132 participants
Official Title : Imaging Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis (IRRAS-BM)
Actual Study Start Date : 2023-12-07
Estimated Primary Completion Date : 2026-07-30
Estimated Study Completion Date : 2026-07-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Imaging Features for the Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis

Location Details

NCT05868928

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Locations

RECRUITING

Korea, Republic of,

Asan Medical Center

Seoul, Korea, Republic of,