Health TrialsbyHealthPanel

MRI in High-Grade Glioma Patients Undergoing Chemoradiation

ConditionHigh Grade Glioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • PET-MRI Brain Scan

    Procedure/Surgery

    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, at 1 month and 3 to 4 months after radiation, participants will have another MRI scan.

  • Blood draw

    Diagnostic test

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

  • Memory testing

    Behavioral

    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 at baseline, one month after radiation, and 3 to 4 months after radiation.

  • Optional lumbar puncture for cerebrospinal fluid collection

    Procedure/Surgery

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

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: PET-MRI In High-Grade Glioma Patients Undergoing ChemoradiationExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Number of Participants to Complete Two PET scans

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

Time frame
At baseline and at 4 months post-treatment
2

Number of Participants to Complete Cognitive Testing

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

Time frame
At baseline and at 4 months post-treatment

Secondary outcomes

1

Change in PET measure Related to Cognitive Decline after Radiation Treatment

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.

Time frame
At baseline and 4 months post-treatment
2

Change in Cerebrospinal Fluid (CSF) Biomarkers Related to Cognitive Decline after Radiation Treatment

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.

Time frame
At baseline and 4 months post-treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now