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

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

NCT ID: NCT05868928

Condition: Brain Metastases
Radiosurgery

Conditions: Official terms:
Neoplasm Metastasis
Brain Neoplasms
Recurrence

Conditions: Keywords:
Imaging
Habitat
Recurrence
Prediction
Radiation necrosis

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Magnetic resonance imaging (MRI)
Description: Pre-and post-contrast enhanced T1-weighted image, T2-weighted image, fluid-attenuated inversion recovery image
Arm group label: Brain metastases patients who received stereotactic radiosurgery

Intervention type: Diagnostic Test
Intervention name: Diffusion-weighted MRI
Description: Diffusion-weighted MRI
Arm group label: Brain metastases patients who received stereotactic radiosurgery

Intervention type: Diagnostic Test
Intervention name: Arterial spin labeling (ASL)
Description: Cerebral blood flow imaging parameter
Arm group label: Brain metastases patients who received stereotactic radiosurgery

Intervention type: Diagnostic Test
Intervention name: Dynamic susceptibility contrast-MRI (DSC-MRI)
Description: Cerebral blood volume and vessel architectural imaging parameters
Arm group label: Brain metastases patients who received stereotactic radiosurgery

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.

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.

Criteria for eligibility:

Study pop:
Patients of tertiary medical center

Sampling method: Probability Sample
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Ho Sung Kim, MD, PhD

Phone: +82230105682
Email: radhskim@gmail.com

Start date: December 7, 2023

Completion date: July 30, 2026

Lead sponsor:
Agency: Asan Medical Center
Agency class: Other

Source: Asan Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05868928