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

NCT05632562 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-11

No results posted yet for this study

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

Interventions

DRUG

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

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.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Jonathan McConathy, MD · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2028-02-01
Completion
2028-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05632562 on ClinicalTrials.gov