MRI in High-Grade Glioma Patients Undergoing Chemoradiation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05212272
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Wake Forest University Health Sciences
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Christina Cramer, MD
Principal Investigator Affiliation	Wake Forest Baptist Comprehensive Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	High Grade Glioma

Additional Details

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.

Arms & Interventions

Arms

: 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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

Site Contact

Study Coordinator

[email protected]

336-716-0892

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