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PET Imaging for Glioblastoma

Phase < 1
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
Able to lie flat and/or still for a minimum of 60 minutes
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group

Study 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
I have or might have a recurring brain tumor.
I can lie flat and still for at least 60 minutes.
I am willing and able to follow the study's schedule and procedures.
My MRI shows my condition worsened within 3 months after radiation and temozolomide therapy.
I need a PET-CT scan as advised by my doctor.
I am a woman who is either postmenopausal or have had surgery to prevent pregnancy.
I am older than 18 years.


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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
Completed Phase 2
Computed Tomography
Completed Phase 2
Fludeoxyglucose F-18
Completed Phase 2

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
743 Previous Clinical Trials
1,569,496 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this research still open?

"Affirmative. Current information on clinicaltrials.gov shows that the trial, which was first initiated on March 15th 2020 is still actively recruiting participants with a goal of enrolling 5 patients from one medical centre."

Answered by AI

What is the scope of participants in this clinical trial?

"Affirmative. Clinicaltrials.gov displays that the clinical trial, which was initially shared on March 15th 2020, is actively searching for participants. 5 people are needed at one location to complete this research project."

Answered by AI
~1 spots leftby Feb 2025