MRI in High-Grade Glioma Patients Undergoing Chemoradiation

Wake Forest University (WFU)

Status: Enrolling

Conditions: High Grade Glioma

Treatments: Behavioral: Memory testing; Procedure: PET-MRI Brain Scan; Diagnostic Test: Blood draw; Procedure: Optional lumbar puncture for cerebrospinal fluid collection

Study type: Interventional

Funder types: Other

Identifiers

NCT05212272

WFBCCC 91221 (Other Identifier)

IRB00080134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

PET-MRI In High-Grade Glioma Patients Undergoing Chemoradiation

Experimental group

Description:

PET scan and MRI scan of the brain, blood draw, and 1-hour of memory testing.

Treatment:

Procedure: Optional lumbar puncture for cerebrospinal fluid collection

Diagnostic Test: Blood draw

Procedure: PET-MRI Brain Scan

Behavioral: Memory testing