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NOT YET RECRUITING
NCT07778979
EARLY_PHASE1

Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy in Gliomas

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

Summary

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.

Official title: Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy for Disease Assessment and Guidance of Catheters in Patients With Recurrent/Progressive Malignant Gliomas Eligible for Catheter-delivered Therapies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-09

Completion Date

2030-11

Last Updated

2026-08-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

[18F]FMISO-PET with contrast-enhanced MRI

Glioma patients enrolled in the main study (IRB 300007756) will complete 4 to 5 imaging visits. Visit 1 will take place prior to participants scheduled surgery. Visit 1 could be two seperate imaging visits between \[18F\]FMISO and \[18F\]FET, if needed. Participants will have three additional \[18F\]FET PET/MRIs at 1 month, 3 months and 6 months post-surgery.

Locations (1)

UAB

Birmingham, Alabama, United States