Recruiting

MRI

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05212272

Conditions

High Grade Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PET-MRI Brain Scan

Blood draw

Memory testing

Optional lumbar puncture for cerebrospinal fluid collection

Study Details

Brief 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, optional lumbar puncture, and blood tests might help investigators predict who might have larger changes in their brain function after radiation.

Conditions

High Grade Glioma

Study ID

NCT05212272

Start date

Sep 2, 2022

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  • Patients taking blood thinners will be excluded from the optional Lumbar Puncture only, they are eligible for participation in the main study-provided they meet inclusion/exclusion criteria

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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, at 1 month and 3 to 4 months after radiation, participants will have another MRI 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 at baseline, one month after radiation, and 3 to 4 months after radiation.

Optional lumbar puncture for cerebrospinal fluid collection

Participants that consent for cerebrospinal fluid collection will have between 6 to 20 ml of cerebrospinal collected at baseline.

Primary outcome measure

  • Number of Participants to Complete Two PET scans [ Time Frame: At baseline and at 4 months post-treatment ]
  • Number of Participants to Complete Cognitive Testing [ Time Frame: At baseline and at 4 months post-treatment ]

Central Contacts and Locations

Central contacts

Principal Investigator

336-716-5772Christina.Cramer@wfusm.edu

Locations

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Principal Investigator

336-716-5772Christina.Cramer@wfusm.edu

Principal Investigator:

Christina Cramer, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-08-17.