Glioblastoma Clinical Trial
Official title:
FDG and FDOPA PET Demonstration of Functional Brain Abnormalities
The purpose of this pilot study will be to conduct a clinical trial using a time-of-flight PET scanner and MRI scanner to test an improved method for differentiating tumor recurrence from radiation necrosis in glioblastoma patients. We will attempt to do so by performing a static and dynamic FDG-PET scan, a static and dynamic FDOPA-PET scan, and a multiparametric MRI scan - then comparing the results with surgical pathology and static FDG-PET scans. We hypothesize that 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. This is important for improving patient outcomes by allowing treating physicians to more accurately tailor treatments. Furthermore, dynamic FDG and FDOPA PET will be combined with high resolution anatomic and physiologic MRI in order to develop a multimodal multiparametric approach for differentiating tumor recurrence from treatment effect.
PRIMARY OBJECTIVES:
I. The primary objective will be to evaluate the diagnostic accuracy of Dynamic PET imaging
in differentiating tumor recurrence from treatment effect (radiation necrosis or
pseudoprogression) in patients previously treated with chemo-radiation therapy for primary
high grade gliomas. This will be accomplished by examining the concordance between the
Dynamic PET imaging prediction and the criterion standard, which will be based on either
surgical pathology or an integrated clinical/MRI determination within a 3-6 month interval
after Dynamic PET imaging.
SECONDARY OBJECTIVES:
I. The diagnostic accuracy of Static PET imaging, advanced MRI, and advanced MRI + Dynamic
PET imaging in differentiating tumor recurrence from radiation-induced necrosis in high grade
glioma patients will be examined in the same exact way as just outlined for Dynamic PET
imaging.
OUTLINE:
Subjects receive 18FDG (first scan) and (18)F-FDOPA (2-14 days from the first scan)
intravenously (IV) slowly over a period of 15-20 seconds and then undergo dynamic PET scans
over a period of 60-90 minutes. CT scans on the subjects are performed before the dynamic PET
scans for 5 minutes. Subjects also undergo MRI brain examinations just prior to the FDOPA
scan over a period of 1 hour, which includes T1 weighed, T1 weighted contrast enhanced, T2
weighted, Diffusion tensor imaging, MR spectroscopy, and Dynamic susceptibility contrast
perfusion weighted (DSC-PWI) imaging.
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