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.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 0 Secondary · Reporting Duration: Up to 6 months
Up to 6 months
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.
Semi-quantitative standardize uptake value (SUV) parametric maps based on static PET scans (last 20 minutes of the dynamic PET scans).
Surgical pathology or 3-6 month interval multidisciplinary clinical evaluation.
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Diagnostic
1 of 1
Experimental Treatment
5 Total Participants · 1 Treatment Group
Primary Treatment: Multiparametric Magnetic Resonance Imaging Scan · No Placebo Group · Phase < 1
DiagnosticExperimental Group · 5 Interventions: Positron Emission Tomography, fluorine F 18 fluorodopa, Multiparametric Magnetic Resonance Imaging Scan, Fludeoxyglucose F-18, Computed Tomography · Intervention Types: Procedure, Radiation, Procedure, Radiation, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2820
Fludeoxyglucose F-18
2008
Completed Phase 2
~460
Computed Tomography
2017
Completed Phase 2
~3410
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months
Who is running the clinical trial?
University of VirginiaLead Sponsor
685 Previous Clinical Trials
1,427,043 Total Patients Enrolled
6 Trials studying Glioblastoma
204 Patients Enrolled for Glioblastoma
Bijoy Kundu, PhD1.01 ReviewsPrincipal Investigator - University of Virginia
University of Virginia
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:This means that the person can stay in the same position for at least 60 minutes.
The subject was willing and able to comply with all scheduled visits and study procedures.
for grade III anaplastic astrocytoma
MRI scans of the patient's brain showed signs of radiographic worsening shortly after radiation and temozolomide therapy had been completed for a grade III anaplastic astrocytoma.
If the patient is female, she must either be post-menopausal or surgically sterile.
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
Conditions
Cancer Related
Treatments