Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy in Gliomas

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07778979
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [18F]FMISO-PET with contrast-enhanced MRI — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 21, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2030
Completion
Nov 30, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Glioma patients enrolled in main study [18F]FMISO and [18F]FET PET/MRI
    FET and FMISO PET/MRI studies will be performed on either 1) same day or 2) separate days within 14 days of each other. Baseline imaging will occur within 21 days before surgery. Every effort will be made to perform these studies within 1 week of each other. FMISO-PET/MRI will be administered first with a four-hour uptake time followed by a dynamic FET-PET/MRI (\<90 min total scan time). For separate scans, FET-PET/MRI will typically be performed first although the order can be switched if needed due to PET tracer production or scanner scheduling. Patients will fast for at least 4 hours prior to FET administration and will undergo dynamic scans. No fasting or other special preparation is required for FMISO studies and imaging will be acquired after a four-hour uptake time. Additional post-surgical FET-PET/MRI scans at 1, 3 and 6 months post will follow the same steps as the separately acquired scans except no additional FMISO-PET/MRI will be performed.

Primary Outcome Measure

To determine the frequency of changes in catheter placement based on standard pre-surgical study-specific MRI versus standard MRI combined with results from FET/FMISO PET/MRI [ Time Frame: Up to 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UABBirminghamAlabama35249-

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