MRI in High-Grade Glioma Patients Undergoing Chemoradiation
A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation
3 other identifiers
interventional
16
1 country
1
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, lumbar puncture, and blood tests might help investigators predict who might have larger changes in their brain function after radiation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 28, 2022
CompletedStudy Start
First participant enrolled
September 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 23, 2026
March 1, 2026
4.2 years
January 14, 2022
March 18, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants to Complete Two PET scans
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
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 Outcomes (2)
Change in PET measure Related to Cognitive Decline after Radiation Treatment
At baseline and 4 months post-treatment
Change in Cerebrospinal Fluid (CSF) Biomarkers Related to Cognitive Decline after Radiation Treatment
At baseline and 4 months post-treatment
Study Arms (1)
PET-MRI In High-Grade Glioma Patients Undergoing Chemoradiation
EXPERIMENTALPET scan and MRI scan of the brain, blood draw, and 1-hour of memory testing.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Cramer, MD
Wake Forest Baptist Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2022
First Posted
January 28, 2022
Study Start
September 2, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share