MRI in High-Grade Glioma Patients Undergoing Chemoradiation

March 18, 2026 updated by: Wake Forest University Health Sciences

A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Comprehensive Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christina Cramer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Newly diagnosed high grade glioma patients that have been recommended 6 weeks of chemoradiation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: 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
Diagnostic test: Blood draw
Blood draws will be taken at baseline, one month after radiation treatment and 3 to 4 months after radiation treatment.
Behavioral: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants to Complete Two PET scans
Time Frame: At 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
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
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
At baseline and at 4 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PET measure Related to Cognitive Decline after Radiation Treatment
Time Frame: At baseline and 4 months post-treatment
Change in cognitive decline is defined as one standard deviation on any neurocognitive test given using the 2-sample t-test (if normally distributed; transformation may be needed) or Wilcoxon rank sum test (if not normally distributed) when appropriate. Investigators will also relate baseline PET measure and change in PET measure to the cognitive change using the Spearman's rank correlation coefficient.
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
Changes in serum and cerebrospinal fluid biomarkers will be related to the cognitive decline at 4 months using the 2-sample t-test or Wilcoxon rank sum test when appropriate. We will also relate baseline and changes in serum and CSF biomarkers to the cognitive change using the Spearman's rank correlation coefficient.
At baseline and 4 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Christina Cramer, MD, Wake Forest Baptist Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00080134
  • P30CA012197 (U.S. NIH Grant/Contract)
  • WFBCCC 91221 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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