Health TrialsbyHealthPanel

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

ConditionsBrain MetastasesRadiosurgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAsan Medical Center

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who underwent stereotactic radiosurgery (SRS, gamma-knife radiosurgery or cyberknife radiosurgery) for brain metastases

One to ten newly diagnosed brain metastases

Patients without acute neurological symptom

Patients with a Karnofsky performance status score of 70 or higher

Disqualifiers

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.

Trial population

Patients of tertiary medical center

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Magnetic resonance imaging (MRI)

    Diagnostic test

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

  • Diffusion-weighted MRI

    Diagnostic test

    Diffusion-weighted MRI

  • Arterial spin labeling (ASL)

    Diagnostic test

    Cerebral blood flow imaging parameter

  • Dynamic susceptibility contrast-MRI (DSC-MRI)

    Diagnostic test

    Cerebral blood volume and vessel architectural imaging parameters

Treatment groups

132 Participants
are divided into 1 treatment group
Group A: Brain metastases patients who received stereotactic radiosurgery4 interventions

Trial outcomes

Primary outcomes

1

Time to progression

The time from the date of SRS for brain metastasis until the date of progression.

Time frame
up to 24 months

Secondary outcomes

1

Response rate

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.

Time frame
up to 24 months
2

Occurence rate of radiation necrosis

The rate of occurrence of radiation necrosis per lesion is determined through a combination of imaging findings and clinical evaluation by a multidisciplinary team.

Time frame
12 months
3

Imaging risk score for recurrence

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.

Time frame
Baseline imaging before SRS, and follow up imaging every 3 months after SRS, up to 24 months
4

Tumor habitat analysis

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.

Time frame
Baseline imaging before SRS, and follow up imaging every 3 months after SRS, up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asan Medical Center

Lead sponsor

Source ClinicalTrials.gov
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