MRI in High-Grade Glioma Patients Undergoing Chemoradiation
NCT ID: NCT05212272
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
16 participants
INTERVENTIONAL
2022-09-02
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PET-MRI In High-Grade Glioma Patients Undergoing Chemoradiation
PET scan and MRI scan of the brain, blood draw, and 1-hour of memory testing.
PET-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
Blood draw
Blood draws will be taken at baseline, one month after radiation treatment and 3 to 4 months after radiation treatment.
Memory 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.
Optional lumbar puncture for cerebrospinal fluid collection
Participants that consent for cerebrospinal fluid collection will have 6 and 20 ml of cerebrospinal collected at baseline.
Interventions
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PET-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
Blood draw
Blood draws will be taken at baseline, one month after radiation treatment and 3 to 4 months after radiation treatment.
Memory 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.
Optional lumbar puncture for cerebrospinal fluid collection
Participants that consent for cerebrospinal fluid collection will have 6 and 20 ml of cerebrospinal collected at baseline.
Eligibility Criteria
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Inclusion Criteria
* ≥18 years of age.
* ECOG performance status of 0 to 3
* Anticipated to receive 6 weeks of chemoradiation
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Christina Cramer, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest Baptist Comprehensive Cancer Center
Locations
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Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00080134
Identifier Type: -
Identifier Source: org_study_id
WFBCCC 91221
Identifier Type: OTHER
Identifier Source: secondary_id