Clinical trial NCT05212272: MRI in High-Grade Glioma Patients Undergoing Chemoradiation
Official title: A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Grade Glioma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants to Complete Two PET scans
timeFrame: 4 months post-treatment
measure: Number of Participants to Complete Cognitive Testing
timeFrame: 4 months post-treatment
Secondary outcomes:
measure: Change in PET measure Related to Cognitive Decline after Radiation Treatment
timeFrame: At baseline and 4 months post-treatment
measure: Change in Cerebrospinal Fluid Biomarkers Related to Cognitive Decline after Radiation Treatment
timeFrame: At baseline and 4 months post-treatment
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: Christina Cramer, MD
role: PRINCIPAL_INVESTIGATOR
References: