Status:

RECRUITING

MRI in High-Grade Glioma Patients Undergoing Chemoradiation

Lead Sponsor:

Wake Forest University Health Sciences

Conditions:

High Grade Glioma

Eligibility:

All Genders

18+ years

Phase:

NA

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 le...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 2 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2026

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT05212272

Start Date

September 2 2022

End Date

January 1 2026

Last Update

December 17 2025

Active Locations (1)

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Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27157