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NCT Number: NCT04073966

MRI Biomarkers for Radiation-Induced Neurocognitive Decline Following SRS of Newly Diagnosed Brain Mets

Brain metastases are a source of much morbidity and mortality in adults with primary solid malignant tumors. With improvements in systemic therapy that prolong survival but have limited central nervous system penetration, patients with brain metastases are at increasing risk of developing and experiencing long-term side effects from treatment of brain metastases. The overarching goal of this study is to better understand the determinants of RT-associated changes in white and gray matter function and associated neurocognitive decline.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Leukoaraiosis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurocognitive Deficit Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Exposure White Matter Alterations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, 27599, United States

About this study

The proposed study aims to provide novel and useful information for clinicians, both to help predict potential neurocognitive changes following SRS, and as a possible guide for SRS treatment alteration, whether through adjustment of dose or beam arrangements in relation to white matter tracts. In this observational pilot study of 20 patients, the association between RT-associated brain injury and neurocognitive function will be quantitatively assessed longitudinally over one year following SRS. The study team hypothesizes that, over this time, (1) there will be radiation dose-dependent reductions in regional white matter tract integrity and reduction in functional connectivity in the default mode network of gray matter, (2) there will be measurable decline in neurocognitive function, and (3) there will be an association between severity of radiation-induced brain injury on MRI and magnitude of neurocognitive functional decline. This association will relate, in part, to the location(s) affected.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologic diagnosis of cancer
  • Newly diagnosed brain metastasis being treated with SRS. Any extent of cranial disease permitted. Subsequent courses of SRS while on study permitted when clinically indicated.
  • Patients are permitted to have undergone craniotomy and resection of metastasis/metastases if at least 1 other intact metastasis planned for definitive SRS is present. Receiving or previously received systemic therapy also permitted.
  • Anticipated life expectancy at least 1 year
  • Age ≥ 18 years
  • Ability to read and comprehend written English and follow instructions in English
  • Ability to provide informed consent

Exclusion criteria

  • Previous radiation to the brain or head
  • Previous malignancy - other than non-melanomatous skin cancer or cervical carcinoma in situ - and not disease-free for at least 3 years
  • Previous severe head or brain injury
  • History of a neurological disorder such as Epilepsy, Parkinson's, Alzheimer's, or Dementia
  • Prisoners

Treatment and study plan

Primary outcomes

  1. Radiation-Induced White Matter Injury

    Time frame: One year after SRS completion

    Dose-dependent reductions in white matter integrity, as quantified by Diffusion Tensor MRI (DTI)-derived measures of change in diffusivity

Secondary outcomes

  1. Changes in Functional Connectivity

    Time frame: One year after SRS completion

    Dose-dependent alterations in functional connectivity, especially for the subsystems of the Default Mode Network (DMN), as measured by resting state functional MRI

  2. Neurocognitive Changes

    Time frame: One year after SRS completion

    Change in neurocognitive function, as measured by Delis-Kaplan testing, after SRS treatment

Other outcomes

  1. Association between Changes in Functional Connectivity and Neurocognitive Changes

    Time frame: One year after SRS completion

    Correlation between magnitude of neurocognitive function decline and severity of radiation-induced brain injury

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

Magnetic Resonance Imaging Biomarkers for Radiation-Induced Neurocognitive Decline Following Stereotactic Radiosurgery of Newly Diagnosed Brain Metastases: An Observational Pilot Study

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Aug 29, 2019
Registry last updated
Jun 3, 2026

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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