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NCT Number: NCT05212272

MRI in High-Grade Glioma Patients Undergoing Chemoradiation

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.

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Key information

Conditions

High Grade Glioma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Christina Cramer, MD

PRINCIPAL_INVESTIGATOR

Principal Investigator

CONTACT

[email protected]

336-716-5772

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET-MRI Brain Scan

Procedure

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

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

Primary outcomes

  1. Number of Participants to Complete Two PET scans

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

    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

  2. Number of Participants to Complete Cognitive Testing

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

    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

Secondary outcomes

  1. Change in PET measure Related to Cognitive Decline after Radiation Treatment

    Time frame: At baseline and 4 months post-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.

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

    Time frame: At baseline and 4 months post-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.

Study contacts

Contact information is provided by the study sponsor or research team.

Principal Investigator

CONTACT

[email protected]

336-716-5772

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2022
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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