Clinical trial · Interventional
MRI in High-Grade Glioma Patients Undergoing Chemoradiation
A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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, optional lumbar puncture, and blood tests might help investigators predict who might have larger changes in their brain function after radiation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Grade Glioma | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw | Diagnostic Test | — | UNRESOLVED |
| Memory testing | Behavioral | — | UNRESOLVED |
| Optional lumbar puncture for cerebrospinal fluid collection | Procedure | — | UNRESOLVED |
| PET-MRI Brain Scan | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET-MRI In High-Grade Glioma Patients Undergoing Chemoradiation
- description
- PET scan and MRI scan of the brain, blood draw, and 1-hour of memory testing.
- interventionNames
- Procedure: PET-MRI Brain Scan
- Diagnostic Test: Blood draw
- Behavioral: Memory testing
- Procedure: Optional lumbar puncture for cerebrospinal fluid collection
Primary outcomes (2)
- measure
- Number of Participants to Complete Two PET scans
- timeFrame
- At baseline and at 4 months post-treatment
- description
- 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
- measure
- Number of Participants to Complete Cognitive Testing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available