Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma

NCT05632562 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: R22-193300010076
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This feasibility study will assess the clinical potential of a new imaging approach to detect viable high grade glioma (HGG) in pediatric and adult patients after standard of care radiation therapy (RT) with or without concurrent temozolomide (TMZ). Study participants will undergo simultaneous positron emission tomography/magnetic resonance imaging (PET/MRI) with O-(\[2-\[F-18\]fluoroethyl)-L-tyrosine (FET, amino acid transport) and 1H-1-(3-\[F-18\]fluoro-2-hydroxypropyl)-2-nitroimidazole (FMISO, hypoxia) at the time of standard of care imaging after completion of RT. The presence of viable tumor at this time point will be assessed on a per patient basis. Study participants will be followed clinically and with standard of care (SOC) imaging for up to 2 years after completion of PET/MRI to determine the nature of lesions seen on investigational imaging and to obtain patient outcome data. The imaging data will also be used to develop a semi-automated workflow suitable for implementation in clinical trials and standard of care PET/MRI studies.

Conditions

High Grade Glioma

Outcome Measures

Primary Outcomes (1)

• Detection of viable glioma based on PET

  The frequency of the detection of viable tumor by FET and/or FMISO based on prespecified standardized uptake values (SUVs) and lesion to normal brain ratios will be measured. We expect to detect viable glioma in at least 25% of patients at this time point.

  Up to 24 months after completing study PET/MRI visits.

Study Arms (1)

PET imaging of system L amino acid transport with FET and hypoxia imaging with FMISO

EXPERIMENTAL

The participant will have a plastic peripheral intravenous (IV) catheter placed in the arm for Positron emission tomography (PET) tracer and MR contrast administration. FET O-(\[2-\[18F\]fluoroethyl)-L-tyrosine and FMISO 1H-1-(3-\[18F\]fluoro-2-hydroxypropyl)-2-nitroimidazole will be produced by the UAB Cyclotron PET Production Facility. PET/MRI will be performed using a GE Signa PET/MRI system in the AIF with specific imaging protocols for FET and FMISO studies. Upon completion of imaging, the peripheral IV catheter will be removed. The participant will be asked to urinate to reduce bladder dose after completion of each PET acquisition.Patients enrolled in the study will be followed clinically and with standard of care brain MRI. PFS and OS will be monitored for up to 24 months after completion of FET and FMISO PET/MRI studies.

Drug: O-(2-[18F]Fluoroethyl)-L-tyrosine, [18F]-FET with PET/MRI

Interventions

O-(2-[18F]Fluoroethyl)-L-tyrosine, [18F]-FET with PET/MRI DRUG

High grade glioma patients that are planning to undergo radiation therapy (RT) and consent to this study will have up to 3 in-person study visits. The first visit will take up to 2 hours, the second visit will take up to 3 hours, and the third visit will take up to 6 hours. After both imaging visits, there will be a phone call at 24-48 hours after imaging.After confirmation of patient eligibility and consent, the administration of FET and FMISO and related procedures will be performed in the UAB Advanced Imaging Facility (AIF) at the time of first standard of care (SOC) MRI after completion of RT (typically a 4-week interval). Patients enrolled in the study will be followed clinically and with standard of care brain MRI. PFS and OS will be monitored for up to 24 months after completion of FET and FMISO PET/MRI studies. Study participants will not undergo additional study related procedures after completion of the FET-PET/MRI and FMISO-PET/MRI studies.

PET imaging of system L amino acid transport with FET and hypoxia imaging with FMISO

Eligibility Criteria

• Age: 10 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed newly diagnosed grade III or grade IV glioma treated with standard of care external beam radiation therapy (RT). For diffuse midline glioma involving the pons (diffuse intrinsic pontine glioma), histological confirmation is not required. Surgical resection of the glioma prior to RT and/or concurrent temozolomide (TMZ) with RT are allowed but not required.
• years of age or older at the time of enrollment
• Able to undergo PET/MRI without anesthesia or sedation. Minimal sedation with an anxiolytic 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 beta-hCG test within 48 hours prior to the administration of FET or FMISO.
• ECOG performance score of 2 or better in adults. For patients less than 16 years of age, Modified Lansky score ≥ 60.
• Life expectancy greater than 12 weeks.

You may not qualify if:

• Recurrent glioma
• Use of bevacizumab or an investigational therapeutic drug for any indication within 3 months prior to the imaging study.
• 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
• Time interval greater than 12 weeks between the completion of RT and performance of FET and FMISO PET/MRI studies.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (2)

UAB

Birmingham, Alabama, 35249, United States

NOT YET RECRUITING

UAB

Birmingham, Alabama, 35249, United States

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

O-(2-fluoroethyl)tyrosine; (18F)fluoroethyltyrosine

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

• Jonathan McConathy, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian M Eady, BS

CONTACT

205-996-2636; smeady@uabmc.edu

Quenteeria S Mooney, BS

CONTACT

205-934-3747; qmooney@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

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 30, 2022
• Study Start: March 7, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)