Neoplasms

All Conditions

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

PET scan and MRI scan of the brain, blood draw, and 1-hour of memory testing.

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

PET-MRI Brain Scan

Blood draws will be taken at baseline, one month after radiation treatment and 3 to 4 months after radiation treatment.

Blood draw

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.

Memory testing

Participants that consent for cerebrospinal fluid collection will have 6 and 20 ml of cerebrospinal collected at baseline.

Optional lumbar puncture for cerebrospinal fluid collection

Study Coordinator

Study Nurse

Christina Cramer, MD

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.

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.

MRI in High-Grade Glioma Patients Undergoing Chemoradiation

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

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

Using a customized abbreviated cognitive battery designed for brain tumor patients to measure a range of cognitive functions affected by cancer and radiation treatment including basic attention, information processing speed, language, learning and recent memory, executive functions (spanning verbal fluency, cognitive set-shifting, and abstract reasoning), and visual perceptual/spatial skills. Premorbid functioning (assessing cognitive reserve) will also be assessed via a single word reading test that is strongly associated with overall intellectual functioning. Most tests have multiple forms to allow for assessment at sequential time points. All tests have well-validated normative data and have been used previously with cancer patients. Fatigue, depression, anxiety, and quality of life will be evaluated simultaneously using standard and validated patient questionnaires

Change in cognitive decline is defined as one standard deviation on any neurocognitive test given using the 2-sample t-test (if normally distributed; transformation may be needed) or Wilcoxon rank sum test (if not normally distributed) when appropriate. Investigators will also relate baseline PET measure and change in PET measure to the cognitive change using the Spearman's rank correlation coefficient.

Changes in serum and cerebrospinal fluid biomarkers will be related to the cognitive decline at 4 months using the 2-sample t-test or Wilcoxon rank sum test when appropriate. We will also relate baseline and changes in serum and CSF biomarkers to the cognitive change using the Spearman's rank correlation coefficient.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MRI in High-Grade Glioma Patients Undergoing Chemoradiation	NCT05212272	High Grade Glio...	PET-MRI Brain S... Blood draw Memory testing Optional lumbar...	18 Years -	Wake Forest University Health Sciences
MRI in High-Grade Glioma Patients Undergoing Chemoradiation	NCT05212272	High Grade Glio...	PET-MRI Brain S... Blood draw Memory testing Optional lumbar...	18 Years -	Wake Forest University Health Sciences
MRI in High-Grade Glioma Patients Undergoing Chemoradiation	NCT05212272	High Grade Glio...	PET-MRI Brain S... Blood draw Memory testing Optional lumbar...	18 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for optional lumbar puncture for cerebrospinal fluid collection