Status:
UNKNOWN
FDG and FDOPA PET Demonstration of Functional Brain Abnormalities
Lead Sponsor:
University of Virginia
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 ne...
Detailed Description
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 pseudo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- \- 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
Key Trial Info
Start Date :
March 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04315584
Start Date
March 15 2020
End Date
June 20 2024
Last Update
March 24 2020
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22903