Actively Recruiting
Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma
Led by University of Alabama at Birmingham · Updated on 2025-12-11
20
Participants Needed
2
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed newly diagnosed grade III or IV glioma treated with standard radiation therapy, or diffuse midline glioma involving the pons without histological confirmation
- Age 10 years or older at enrollment
- Able to undergo PET/MRI without anesthesia or sedation; minimal anxiolytic sedation allowed
- Females with childbearing potential must have a negative pregnancy test on the day of procedure or within 48 hours prior
- ECOG performance score of 2 or better for adults; Modified Lansky score 60 or higher for patients under 16
- Life expectancy greater than 12 weeks
You will not qualify if you...
- Recurrent glioma
- Use of bevacizumab or investigational therapeutic drugs within 3 months prior to imaging
- Pregnancy or breastfeeding
- Unable to complete PET/MRI scans
- Significant kidney problems (estimated GFR less than 30 mL/min)
- Any condition interfering with participation or completion of study activities
- More than 12 weeks between finishing radiation therapy and PET/MRI scans
AI-Screening
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Trial Site Locations
Total: 2 locations
1
UAB
Birmingham, Alabama, United States, 35249
Not Yet Recruiting
2
UAB
Birmingham, Alabama, United States, 35249
Actively Recruiting
Research Team
S
Sebastian M Eady, BS
CONTACT
Q
Quenteeria S Mooney, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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