FDG and FDOPA PET Demonstration of Functional Brain Abnormalities

Status unconfirmed · Early Phase 1

Conditions studied: Glioblastoma

In brief

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.

Key facts

Study ID

NCT04315584

Run by

University of Virginia

People needed

5

Starts

2020-03-15

Expected to finish

2024-06-20

Last updated by the study team

2020-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18
• Known or suspected recurrent malignant brain tumors
• Radiographic worsening reported on MRI shortly (within 3 months) after completion of radiation and temozolomide therapy
• Able to lie flat and/or still for a minimum of 60 minutes
• Willingness and ability to comply with scheduled visits and study procedures
• Patients who have a clinical indication for a PET-CT
• If female, patient must be postmenopausal or surgically sterile

You may not qualify if…

• 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
• Conditions that preclude a FDOPA PET study, including: Consuming a diet that is NOT low in protein after the previous evening meal
• Tumor located in the striatum
• Changes in medication (new prescriptions or change in dosages) between visits 1 and 2
• Pregnant, nursing, or lactating
• Women of childbearing potential (premenopausal female capable of becoming pregnant), which also includes:
• women on oral, injectable, or mechanical contraceptives, women who are single, women whose male partners have been vasectomized or whose male partners have received or are utilizing mechanical contraceptive devices
• Weight > 450 lbs
• Known allergic reactions to 3,4-dihydroxy-6-[18F]fluoro-L-phenylalanine (18F-FDOPA) and Fluorine-18 fluorodeoxyglucose (18F-FDG)
• Confirmation that study eligibility criteria have not been met between visits 1 and 2

Where it is running

• University of Virginia — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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