Clinical Trial · NCT07778979

Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy in Gliomas

Overview

This substudy will investigate a new imaging approach using positron emission tomography (PET) and two investigational drugs (\[18F\]FET and \[18F\]FMISO) to see if the imaging results will help with the placement of catheters for therapy delivery in 20 adult patients with malignant gliomas (MGs) who are participating in the UAB IRB approved main study, A Phase I/II Study of Pembrolizumab and M032 (NSC 733972), a Genetically Engineered HSV-1 Expressing IL-12, in Patients with Recurrent/Progressive and Newly Diagnosed Glioblastoma Multiforme, grade 3 or grade 4 astrocytoma, or Gliosarcoma (IRB 300007756 PI Markert). The PET and MR imaging results will be available to guide catheter placement within IRB 300007756 study-specific guidelines during Neurosurgery.

Sponsor

University of Alabama at Birmingham

Phase

Early Phase 1

Contacts

Sebastian Eady (CONTACT)

smeady@uabmc.edu

205-996-2636

Anna Sorace, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07778979

Drug / Compound

FMISO

Isotope(s):

Target(s):

Hypoxia

Ligand Class: Small Molecules

FET

Isotope(s):

Target(s):

Amino Acid Transport

Ligand Class: Small Molecules

Eligibility

Inclusion

ECOG performance score of 2 or better
Able to undergo PET/MRI without anesthesia or sedation. Minimal sedation with ananxiolytic such as alprazolam used routinely for SOC MRI is allowed.

Exclusion

Significant renal dysfunction (estimated GFR \< 30 mL/min)