Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy in Gliomas

NCT07778979 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB-300017146
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• The variance of mathematical modeling predicted tumor volume to imaging-derived tumor volume (Standard-of-care; FET PET/MRI).

  Up to 24 weeks

Study Arms (1)

Glioma patients enrolled in main study [18F]FMISO and [18F]FET PET/MRI

EXPERIMENTAL

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.

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

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.

Glioma patients enrolled in main study [18F]FMISO and [18F]FET PET/MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants from IRB 300007756
• years of age or older at the time of enrollment
• Able to undergo PET/MRI without anesthesia or sedation. Minimal sedation with ananxiolytic such as alprazolam used routinely for SOC MRI is allowed.
• 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.
• ECOG performance score of 2 or better
• Life expectancy greater than 12 weeks.

You may not qualify if:

• Pregnancy or breast feeding
• Inability to complete PET/MRI scans.
• Significant renal dysfunction (estimated GFR \< 30 mL/min)
• Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team
• Unable to undergo MRI
• Contraindication to gadolinium-based contrast

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Anna Sorace, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Eady

CONTACT

205-996-2636; smeady@uabmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Radiology and Biomedical Engineering Division Director, Advanced Medical Imaging Research Division Director, Small Animal Imaliging Shared Facity

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)