Predicting brain function changes in high-grade glioma patients after radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to predict changes in brain function following radiation treatment in patients with high-grade glioma by utilizing PET scans, blood tests, and cognitive assessments. The primary objective is to assess the feasibility of interim PET-MRI in these patients, focusing on their survival and cognitive performance four months post-treatment. Secondary objectives include exploring correlations between early PET changes and cognitive decline, as well as identifying biomarkers in blood or cerebrospinal fluid that may indicate cognitive impairment. The study involves multiple interventions, including brain scans, blood draws, and memory testing.

Why it matters

Who can join: the full rules

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

Where it's running

• Wake Forest Baptist Comprehensive Cancer Center
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Christina Cramer, MD — Wake Forest Baptist Comprehensive Cancer Center
• Study coordinator: Principal Investigator
• Email: Christina.Cramer@wfusm.edu
• Phone: 336-716-5772

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Taste of hope: testing NRG-103 safety and dosing for adults with high-grade glioma

  This early-phase trial tests whether NRG-103 is safe and tolerable in adults with recurrent or progressive high-grade glioma and looks for early signs it might help.

  Recruiting at 2 sites Phase 1 Neuregen Therapeutics Co., Ltd. · Shanghai and 2 other locations · NCT07710690

• Dual-target CAR-NK cell therapy for recurrent glioblastoma and high-grade glioma

  This phase 1 study will test whether injecting dual-target CAR-NK cells into the brain is safe and can help adults with recurrent or progressive glioblastoma or other high-grade gliomas.

  Recruiting Phase 1 Beijing Biotech · Shenzhen, Guangdong · NCT07480941

• Intratumoral DNX-2401 for High-Grade Pediatric Brain Tumors

  This study tests whether a single injection of DNX-2401 into a pediatric brain tumor can help shrink the tumor and extend survival in kids and young adults with recurrent or refractory high-grade brain tumors.

  Recruiting Phase 2 Clinica Universidad de Navarra, Universidad de Navarra · Utrecht and 1 other locations · NCT07424092

• LMP744 (an indenoisoquinolone) for people with recurrent glioblastoma

  This trial will test whether the drug LMP744 can shrink tumors or slow progression in adults whose glioblastoma has returned after prior treatment.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07416188

• Fluorescence-enhanced stereotactic biopsy needle for tumor and vessel detection

  This project will test a biopsy needle fitted with 5-ALA fluorescence, Raman spectroscopy, and ultrasound to see if it can identify tumor tissue and blood vessels in adults with high-grade glioma.

  Recruiting Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Milan · NCT07286903

• Fluorescent-labeled nivolumab (Nivo800) imaging for high-grade glioma surgery

  This trial tests whether a near-infrared fluorescent version of the immunotherapy drug nivolumab can be given before planned surgery to visualize drug distribution in adults with suspected high-grade glioma.

  Recruiting Early Phase 1 Vanderbilt-Ingram Cancer Center · Nashville, Tennessee · NCT07210632

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.