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RecruitingNCT04073966

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

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

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

15 participants

Start Date

Dec 4, 2019

Study Type

OBSERVATIONAL

Conditions

Brain MetastasesRadiation ExposureNeurocognitive DeficitWhite Matter Alterations

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria5

  • 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

Locations(1)

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

Chapel Hill, North Carolina, United States

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NCT04073966

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