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

Sponsor

Asan Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05868928

Collaborator

(none)

132

Enrollment

Location

37.7

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Brain Metastases 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)

Detailed Description

PRIMARY OBJECTIVE:

To develop an imaging risk score for recurrence after stereotactic radiosurgery (SRS) in brain metastasis using multiparametric MRI.
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, 3-6 months after SRS, and then every 6-9 months.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

132 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Imaging Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis (IRRAS-BM)

Anticipated Study Start Date :

Jun 10, 2023

Anticipated Primary Completion Date :

Jul 30, 2026

Anticipated Study Completion Date :

Jul 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Brain metastases patients who received stereotactic radiosurgery Patients with brain metastases who received stereotactic radiosurgery	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

Arm

Intervention/Treatment

Brain metastases patients who received stereotactic radiosurgery

Patients with brain metastases who received stereotactic radiosurgery

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

Outcome Measures

Primary Outcome Measures

Time to progression [up to 24 months]
The time from the date of SRS for brain metastasis until the date of progression.

Secondary Outcome Measures

Response rate [up to 24 months]
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.
Occurence rate of radiation necrosis [12 months]
The rate of occurrence of radiation necrosis per lesion is determined through a combination of imaging findings and clinical evaluation by a multidisciplinary team.
Imaging risk score for recurrence [Baseline imaging before SRS, and follow up imaging 3-6 months after SRS, and then every 6-9 months, up to 24 months]
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.
Tumor habitat analysis [Baseline imaging before SRS, and follow up imaging 3-6 months after SRS, and then every 6-9 months, up to 24 months]
Automated process of tumor habitat analysis will include followings. A. 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. B. Structural MRI habitats: enhancing tissue habitat, solid low-enhancing habitat, and nonviable tissue habitat C. Physiologic MRI habitats: hypervascular cellular habitat, hypovascular cellular habitat, and nonviable tissue habitat.. D. Quantitative measurement of each habitat will be performed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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, with the largest tumor <10 mL in volume and <3 cm in longest diameter, and the total cumulative volume ≤15 mL.

Patients with a Karnofsky performance status score of 70 or higher
Patients who underwent brain MRI within 2 months of enrollment
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.

Exclusion criteria:

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.