University of Alabama at Birmingham
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.
Pre-Study Consent Visit This visit will take 0.5 hours and may take place during your neuro-oncology clinic visit or in the Division of Molecular Imaging and Therapeutics in Jefferson Tower or the Wallace Tumor Institute. Participants will be asked to sign this consent form before any study procedures. Participants will have a blood test to measure their kidney function. If participants have already had lab tests to determine kidney function within 4 weeks, they do not have to be repeated. Women of childbearing potential will have a urine pregnancy test or have had a blood test within 48 hour…
Inclusion Criteria: 1. Participants from IRB 300007756 2. 18 years of age or older at the time of enrollment 3. Able to undergo PET/MRI without anesthesia or sedation. Minimal sedation with ananxiolytic such as alprazolam used routinely for SOC MRI is allowed. 4. Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum hCG test within 48 hours prior to the administration of FET or FMISO. 5. ECOG performance score of 2 or better 6. Life expectancy greater than 12 weeks. Exclusion Criteria: 1. Any exclusions listed in IRB 300007756 2. Pregna…
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.
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