A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation
Summary
The purpose of this research study is to see if investigators can predict how brain functioning changes after radiation treatment based on PET scans and blood tests. Most participants experience at least mild decreases in their memory or attention after radiation therapy. Investigators hope that PET scans, lumbar puncture, and blood tests might help investigators predict who might have larger changes in their brain function after radiation.
Detailed description
Primary Objective: To determine the feasibility of interim PET-MRI in high-grade glioma patients undergoing chemoradiation by quantifying the proportion of high-grade glioma patients who are alive at 4 months post-radiation treatment and who have completed two PET scans and abbreviated cognitive testing pre-radiation treatment and at 4 months post radiation treatment. Secondary Objectives * To determine by machine learning if early changes on FDG-PET correlate with cognitive decline after radiation treatment. Cognitive impairment will be defined as a 1 standard deviation decline on any test. * To determine if baseline serum or cerebrospinal fluid markers or the change from baseline to 1-month are associated with patients with cognitive decline at 4-months after radiation treatment (defined as a 1 standard deviation decline on any test) compared to those without decline.
Arms & interventions
- ProcedurePET-MRI Brain Scan
Before starting radiation, participants will have a PET scan and MRI scan of the brain. After 2 to 3 weeks of radiation treatments, participants will have a repeat PET scan. Then 1 month after radiation participants will have another PET scan
- Diagnostic TestBlood draw
Blood draws will be taken at baseline, one month after radiation treatment and 3 to 4 months after radiation treatment.
- BehavioralMemory testing
3 sessions with simple tests to evaluate how the brain is working. These tests primarily check things like memory, attention, and thought process. The whole set of tests will take 1 hour each time.
- ProcedureOptional lumbar puncture for cerebrospinal fluid collection
Participants that consent for cerebrospinal fluid collection will have 6 and 20 ml of cerebrospinal collected at baseline.
Outcome measures
Primary
Number of Participants to Complete Two PET scans
Feasibility is defined as 70% of patients who complete two PET scans. This proportion and its 95% confidence interval will be calculated at 4 months
Time frame: At baseline and at 4 months post-treatment
Number of Participants to Complete Cognitive Testing
Using a customized abbreviated cognitive battery designed for brain tumor patients to measure a range of cognitive functions affected by cancer and radiation treatment including basic attention, information processing speed, language, learning and recent memory, executive functions (spanning verbal fluency, cognitive set-shifting, and abstract reasoning), and visual perceptual/spatial skills. Premorbid functioning (assessing cognitive reserve) will also be assessed via a single word reading test that is strongly associated with overall intellectual functioning. Most tests have multiple forms to allow for assessment at sequential time points. All tests have well-validated normative data and have been used previously with cancer patients. Fatigue, depression, anxiety, and quality of life will be evaluated simultaneously using standard and validated patient questionnaires
Time frame: At baseline and at 4 months post-treatment
Secondary
Change in PET measure Related to Cognitive Decline after Radiation Treatment
Time frame: At baseline and 4 months post-treatment
Change in Cerebrospinal Fluid (CSF) Biomarkers Related to Cognitive Decline after Radiation Treatment
Time frame: At baseline and 4 months post-treatment
Eligibility criteria
Study locations (1)
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157