PRIMARY OBJECTIVES:
I. To determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.
II. To compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.
SECONDARY OBJECTIVES:
I. To determine correlation between concordance of 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival.
OUTLINE:
Beginning at no more than 1 week before biopsy and resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy.
After completion of study treatment, patients are followed up every year for 5 years.
Inclusion Criteria:
- Age ≥18 years.
- MRI findings compatible with newly diagnosed high- or low-grade malignant glioma
- Planned craniotomy and resection or biopsy
- Willing to sign release of information for any radiation and/or follow-up records
- Negative pregnancy test done =< 48 hours of injection of study drug, for women of childbearing potential only
- Provide informed written consent
- Patients with eGFR < 60 mg/min/1.72m2 are eligible for the study; PLEASE NOTE: the patient is not eligible to receive the contrast for the pMRI at the study dose.
Exclusion Criteria:
- Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)
- Unable to undergo an 18F-FDOPA PET scan (e.g. Parkinson's Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists)
- Pregnant women; nursing women; men or women of childbearing potential who are unwilling to employ adequate contraception
Last updated: 10/16/2012
NCT ID: NCT01165632
IRB Number:10-001904
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