Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma

Location:

Rochester, MN.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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