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Trial Title:
Longitudinal Prospective Study of Neurocognition & Neuroimaging in Primary BT Patients
NCT ID:
NCT05576103
Condition:
Primary Brain Tumor
Glioma
Meningioma
Schwannoma
Conditions: Official terms:
Brain Neoplasms
Meningioma
Neurilemmoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
In this proposal, the investigators introduce a novel, translational study to
prospectively examine primary brain tumor patients undergoing fractionated radiation
therapy to the brain. Quantitative neuroimaging, radiation dose information, and directed
neurocognitive testing will be acquired through this study to improve understanding of
cognitive changes associated with radiation dosage to non-targeted tissue, and will
provide the basis for evidence-based cognitive- sparing brain radiotherapy.
Detailed description:
Background: Fractionated radiation therapy (RT) is a mainstay in the treatment of primary
and metastatic brain tumors. However, RT to the brain is associated with an inevitable
decline in neurocognitive function in up to 90% of patients who survive more than 6
months after irradiation. Radiation to the brain results in an inevitable decline in
neurocognitive function, mediated by tissue injury to white matter, cortex and
subcortical areas. With quantitative magnetic resonance imaging (MRI) techniques,
investigators can directly and non-invasively measure such changes.
Objective/Hypothesis:
The purpose of this study is to examine radiation-induced imaging changes in normal brain
tissue over time in primary brain tumor patients, and correlate these with neurocognitive
outcomes. The overarching goal is to better identify sensitive brain regions so that
future radiation techniques can be optimally designed to mitigate collateral damage.
Specific Aims:
1. To identify microstructural changes in subcortical white matter, hippocampus, and
cortex associated with quantified regional exposure to fractionated brain
radiotherapy using advanced quantitative neuroimaging imaging
2. To identify changes in neurocognitive functioning in primary brain tumor patients
after brain radiotherapy
Study Design:
The investigators will prospectively enroll primary brain tumor patients undergoing
fractionated partial brain radiation therapy. Patients will undergo volumetric and
diffusion brain MRI (per clinical standard-of-care) and a neurocognitive battery of tests
at baseline (pre-treatment), 3 months, 6 months, and 12 months post-treatment. Clinical
data including age, gender, educational status, tumor size and histology, steroid use,
antiepileptic drug use and chemotherapy will be recorded.
Criteria for eligibility:
Study pop:
Primary brain tumor patients
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Patients 18 years or older
2. Karnofsky performance status (KPS) ≥70
3. Life expectancy of ≥1 year
4. Primary brain tumor patients who will receive fractionated partial brain RT
5. Able to complete neurocognitive assessments
Exclusion Criteria:
1. Inability to undergo MRI with contrast
2. Prior brain RT
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Moores Cancer Center
Address:
City:
San Diego
Zip:
92037
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lara J Rose
Phone:
858-822-6575
Email:
s4medina@health.ucsd.edu
Contact backup:
Last name:
Jona Hattangadi-Gluth, MD
Start date:
January 2015
Completion date:
December 2026
Lead sponsor:
Agency:
Jona Hattangadi-Gluth
Agency class:
Other
Source:
University of California, San Diego
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05576103
