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NCT Number: NCT05868928

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Patients without acute neurological symptom
  • Patients with a Karnofsky performance status score of 70 or higher
  • Patients who underwent brain MRI within 1 month 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.
  • A longest diameter > 1.5 cm for tumor habitat analysis.

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.

Treatment and study plan

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

Primary outcomes

  1. Time to progression

    Time frame: up to 24 months

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

Secondary outcomes

  1. Response rate

    Time frame: 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.

  2. Occurence rate of radiation necrosis

    Time frame: 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.

  3. Imaging risk score for recurrence

    Time frame: Baseline imaging before SRS, and follow up imaging every 3 months after SRS, 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.

  4. Tumor habitat analysis

    Time frame: Baseline imaging before SRS, and follow up imaging every 3 months after SRS, 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ho Sung Kim, MD, PhD

CONTACT

[email protected]

+82230105682

Ji Eun Park, MD, PhD

CONTACT

[email protected]

+82230101505

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 22, 2023
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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