MRI in High-Grade Glioma Patients Undergoing Chemoradiation
A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation
Wake Forest University Health Sciences
16 participants
Sep 2, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Pathologically confirmed diagnosis of high-grade glioma (grade III or IV) or WHO grade II glioma, IDH wildtype (molecular glioblastoma multiforme \[GBM\]).
- ≥18 years of age.
- ECOG performance status of 0 to 3
- Anticipated to receive 6 weeks of chemoradiation
Exclusion Criteria11
- Does not speak or read English
- Unable to participate in cognitive testing due to aphasia or other severe cognitive impairment as determined by the PI, or Dr. Cummings or her designee.
- Unable to give informed consent
- Past medical history of any kind of dementia or diagnosed with mild cognitive impairment prior to diagnosis with their brain tumor
- Unable to safely fast for 8 hours prior to bloodwork or 6 hours prior to PET scan
- Currently taking cognition-enhancing medications including:
- Donepezil
- Memantine
- Armodafinil
- Methylphenidate
- Pregnant or nursing mothers.
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Interventions
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
Blood draws will be taken at baseline, one month after radiation treatment and 3 to 4 months after radiation treatment.
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.
Participants that consent for cerebrospinal fluid collection will have 6 and 20 ml of cerebrospinal collected at baseline.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05212272