RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-12-04
Study Completion:2026-09-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04073966

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologic diagnosis of cancer
  2. * 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.
  3. * 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.
  4. * Anticipated life expectancy at least 1 year
  5. * Age ≥ 18 years
  6. * Ability to read and comprehend written English and follow instructions in English
  7. * Ability to provide informed consent
  1. * Previous radiation to the brain or head
  2. * Previous malignancy - other than non-melanomatous skin cancer or cervical carcinoma in situ - and not disease-free for at least 3 years
  3. * Previous severe head or brain injury
  4. * History of a neurological disorder such as Epilepsy, Parkinson's, Alzheimer's, or Dementia
  5. * Prisoners

Contacts and Locations

Study Contact

Becky Green
CONTACT
9849748440
rlgreen@med.unc.edu

Principal Investigator

Colette J Shen, MD, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Tong Zhu, PhD, DABR
PRINCIPAL_INVESTIGATOR
University of North Carolina at Chapel Hill, Department of Radiation Oncology

Study Locations (Sites)

University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Colette J Shen, MD, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina at Chapel Hill, Department of Radiation Oncology
  • Tong Zhu, PhD, DABR, PRINCIPAL_INVESTIGATOR, University of North Carolina at Chapel Hill, Department of Radiation Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-04
Study Completion Date2026-09-15

Study Record Updates

Study Start Date2019-12-04
Study Completion Date2026-09-15

Terms related to this study

Additional Relevant MeSH Terms

  • Brain Metastases
  • Neurocognitive Deficit
  • White Matter Alterations
  • Radiation Exposure