NCT07778979|Not Yet RecruitingEarly Phase 1DMCFDA Drug
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Sponsor study identifier
Secondary identifiers
NIH
interventional
20
1 country
1
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 18, 2026
Actual (reported)August 21, 2026
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Incidence and frequency that catheter placement changes following the addition of FET/FMISO PET/MRI.
Up to 24 weeks
The percent change in imaging metrics associated with FET-PET/MRI (PET (SUV) and MRI metrics (ADC, Ktrans)) from subsequent imaging visits to the baseline.
The incidence and percent change of PET (SUV) and MRI metrics (ADC, Ktrans) from subsequent imaging visits to the baseline.
Up to 24 weeks
The variance of mathematical modeling predicted tumor volume to imaging-derived tumor volume (Standard-of-care; FET PET/MRI).
Up to 24 weeks
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.
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.
UAB
Birmingham, Alabama, 35249, United States
Anna Sorace, PhD
University of Alabama at Birmingham
First Submitted
August 18, 2026
First Posted
August 21, 2026
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
Contact the study team to confirm eligibility.
November 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 30, 2026
Record last verified: 2026-10
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