Actively Recruiting

Early Phase 1
Age: 10Years - 89Years
All Genders
NCT05632562

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

Age: 10Years - 89Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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