NCT05212272

MRI in High-Grade Glioma Patients Undergoing Chemoradiation

A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• High Grade Glioma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-02
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-01-28
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study