← Back to Search

PET Imaging for Glioblastoma

Phase < 1
Waitlist Available
Led By Bijoy Kundu, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Known or suspected recurrent malignant brain tumors
If female, patient must be postmenopausal or surgically sterile
Must not have
Known allergic reactions to 3,4-dihydroxy-6-[18F]fluoro-L-phenylalanine (18F-FDOPA) and Fluorine-18 fluorodeoxyglucose (18F-FDG)
Conditions that preclude a clinical brain FDG PET study, including: Consumption of liquids with sugar and/or caffeine prior to the study, Blood glucose levels over 150 mg/mL, Eating or drinking calories of any type within 4 hours of radiotracer injection, Hyperinsulinemia, Patients who for any reason cannot tolerate lying supine for 60 minutes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Summary

This trial will use a PET scanner to test an improved method for differentiating tumor recurrence from radiation necrosis in glioblastoma patients. The new quantitative kinetic analytical methods using FDOPA in combination with FDG will provide crucial functional information to distinguish recurrent tumors from treatment-induced radiation changes in patients with treated brain neoplasms.

Who is the study for?
This trial is for adults over 18 with glioblastoma who've seen their cancer worsen on MRI after recent radiation and chemotherapy. They must be able to lie still for an hour, follow the study plan, and have a clinical need for PET-CT scans. Women must be postmenopausal or surgically sterile. Exclusions include pregnancy, potential childbearing without effective contraception, excessive weight, certain dietary habits before tests, high blood sugar levels, and inability to lie flat.Check my eligibility
What is being tested?
The trial is testing new ways to tell if brain tumors in glioblastoma patients are coming back or just changes from treatment using advanced PET and MRI scans with FDG (a glucose-based tracer) and FDOPA (an amino acid-based tracer). Researchers think these methods could help doctors better decide on treatments by providing more accurate information about the tumor's status.See study design
What are the potential side effects?
Potential side effects may include discomfort from lying still during scans and reactions to tracers like FDG or FDOPA such as allergic responses. The risks associated with standard PET-CTs and MRIs also apply here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have or might have a recurring brain tumor.
Select...
I am a woman who is either postmenopausal or have had surgery to prevent pregnancy.
Select...
I need a PET-CT scan as advised by my doctor.
Select...
I am older than 18 years.
Select...
I can lie flat and still for at least 60 minutes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not allergic to 18F-FDOPA or 18F-FDG.
Select...
I haven't consumed sugar, caffeine, or any calories 4 hours before a PET scan and can lie flat for an hour.
Select...
My tumor is located in a specific part of my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MRI brain metrics
Quantitative parametric maps indicating differences in details (d) components of the wavelet transform analysis, d6 and d8, based on established tumor feature criterions.
Quantitative parametric maps indicating differences in rates of glucose and amino acid uptake (Ki) obtained from dynamic FDG and FDOPA scans respectively.
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: DiagnosticExperimental Treatment5 Interventions
Study subjects will receive 18FDG via an IV before undergoing one PET/CT scan over 60 minutes. They will then receive an IV injection of Gadovist for contrast before undergoing a multiparametric MRI scan. Subjects will also receive (18)F-FDOPA via an IV before undergoing another PET/CT scan over 60 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2210
Computed Tomography
2017
Completed Phase 2
~2720
Fludeoxyglucose F-18
2018
Completed Phase 4
~590

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
761 Previous Clinical Trials
1,256,033 Total Patients Enrolled
6 Trials studying Glioblastoma
204 Patients Enrolled for Glioblastoma
Bijoy Kundu, PhD1.01 ReviewsPrincipal Investigator - University of Virginia
University of Virginia

Media Library

Multiparametric Magnetic Resonance Imaging Scan Clinical Trial Eligibility Overview. Trial Name: NCT04315584 — Phase < 1
Glioblastoma Research Study Groups: Diagnostic
Glioblastoma Clinical Trial 2023: Multiparametric Magnetic Resonance Imaging Scan Highlights & Side Effects. Trial Name: NCT04315584 — Phase < 1
Multiparametric Magnetic Resonance Imaging Scan 2023 Treatment Timeline for Medical Study. Trial Name: NCT04315584 — Phase < 1
~1 spots leftby Jul 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top