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NCT05212272 | RECRUITING | High Grade Glioma

MRI in High-Grade Glioma Patients Undergoing Chemoradiation
Sponsor:

Wake Forest University Health Sciences

Brief 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.

Condition or disease

High Grade Glioma

Intervention/treatment

PET-MRI Brain Scan

Blood draw

Memory testing

Optional lumbar puncture for cerebrospinal fluid collection

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 16 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation
Actual Study Start Date : 2022-09-02
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
MRI in High-Grade Glioma Patients Undergoing Chemoradiation

Location Details

NCT05212272

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How to Participate

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Locations

RECRUITING

United States, North Carolina

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27157