← Back to Search

PET Imaging for Glioblastoma

Q: Is recruitment for this research still open?

<p>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.</p>

Q: What is the scope of participants in this clinical trial?

<p>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.</p>

Phase < 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

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

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

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

~2240

Computed Tomography

2017

Completed Phase 2

~2720

Fludeoxyglucose F-18

2018

Completed Phase 4

~560

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

756 Previous Clinical Trials

1,245,301 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

Recent research and studies

clinicaltrials.govStudy

FDG and FDOPA PET Demonstration of Functional Brain Abnormalities

Bijoy Kundu 2020. "FDG and FDOPA PET Demonstration of Functional Brain Abnormalities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04315584.

All > Recurrent Glioblastoma > Glioblastoma Multiforme