MRI in High-Grade Glioma Patients Undergoing Chemoradiation

This study aims to understand how brain function changes after radiation treatment for high-grade glioma (a type of brain cancer). Researchers want to see if special scans (PET-MRI brain scans) and blood tests can predict who might experience changes in memory or attention after radiation. You would have PET-MRI scans, blood draws, and memory testing. Some participants may also have an optional lumbar puncture (spinal tap) to collect cerebrospinal fluid. The study will look at how many participants complete these tests and scans. You may be able to join if you are at least 18 years old, have high-grade glioma, and are expected to receive 6 weeks of chemoradiation. The study is currently unclear on its recruitment status and plans to enroll 16 participants.

Study design
This is an interventional study with no specified phase, planning to enroll 16 participants. It is not stated if it is randomized or blinded.
What's involved
You would have PET-MRI brain scans before radiation, 2-3 weeks into radiation, and 1 month after radiation. Blood draws are taken at the start, one month after radiation, and 3-4 months after radiation. Memory testing involves three 1-hour sessions.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 4 months after radiation treatment to complete PET scans and cognitive testing.

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NCT05212272

MRI in High-Grade Glioma Patients Undergoing Chemoradiation

Recruiting
NAAges 18+InterventionalDiagnostic
Wake Forest University Health Sciences
~16 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:PET-MRI Brain ScanBlood drawMemory testingOptional lumbar puncture for cerebrospinal fluid collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants to Complete Two PET scans
Measured over At baseline and at 4 months post-treatment
+1 more outcome measured
High Grade Glioma
1 sites across 1 states
North Carolina1
  • Christina Cramer, MD · PRINCIPAL_INVESTIGATOR · Wake Forest Baptist Comprehensive Cancer Center

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Eligibility criteria

Inclusion

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

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.
  • Number of Participants to Complete Two PET scansAt baseline and at 4 months post-treatment

    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

  • Number of Participants to Complete Cognitive TestingAt baseline and at 4 months post-treatment

    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