Predicting brain function changes in high-grade glioma patients after radiation
A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation
This study is trying to see if brain scans and blood tests can help predict how radiation treatment affects brain function and memory in patients with high-grade glioma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05212272 on ClinicalTrials.gov |
What this trial studies
This research aims to predict changes in brain function following radiation treatment in patients with high-grade glioma by utilizing PET scans, blood tests, and cognitive assessments. The primary objective is to assess the feasibility of interim PET-MRI in these patients, focusing on their survival and cognitive performance four months post-treatment. Secondary objectives include exploring correlations between early PET changes and cognitive decline, as well as identifying biomarkers in blood or cerebrospinal fluid that may indicate cognitive impairment. The study involves multiple interventions, including brain scans, blood draws, and memory testing.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of high-grade glioma who are expected to undergo chemoradiation.
Not a fit: Patients with severe cognitive impairment, dementia, or those unable to participate in cognitive testing will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for significant cognitive decline after radiation therapy, allowing for tailored interventions.
How similar studies have performed: While similar studies have explored cognitive outcomes in glioma patients, this specific approach using PET-MRI and machine learning for prediction is relatively novel.
Eligibility criteria
Show full 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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Christina Cramer, MD — Wake Forest Baptist Comprehensive Cancer Center
- Study coordinator: Study Coordinator
- Email: Emily.Teal@advocatehealth.org
- Phone: 336-716-5772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.