MRI in High-Grade Glioma Patients Undergoing Chemoradiation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PET-MRI Brain Scan, Blood draw, Memory testing, Optional lumbar puncture for cerebrospinal fluid collection.
- Who it may be relevant to
- Registry conditions: High Grade Glioma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Change in PET measure Related to Cognitive Decline after Radiation Treatment [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem
Identifiers
NCT: NCT05212272 · IRB00080134 · WFBCCC 91221 · P30CA012197