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NCT07778979 · ClinicalTrials.gov record · last posted 2026-08-24

Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy in Gliomas

StatusNot Yet Recruiting
PhaseEarly Phase 1
Started2026-09
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from the ClinicalTrials.gov record
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.

Protocol amendment history 1 change detected by DataLookout

2026-08-25
Primary endpoint(s) modified
WasTo 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, To investigate the change in imaging metrics associated with FET-PET/MRI during therapy. We will compare percent change of PET (SUV) and MRI metrics (ADC, Ktrans) from subsequent imaging visits to the baseline.
NowThe 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, 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.
Trial Details
NCT Number NCT07778979
Lead Sponsor University of Alabama at Birmingham
Conditions Glioma
Enrollment 20 participants
Start Date 2026-09
Primary Completion 2030-11 (estimated)
Study Completion 2030-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-24