Clinical Trial: 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
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Pilot Study of Utility of 18F-FDOPA-PET for Neurosurgical Planning and Radiotherapy Target Delineation in Glioma Patients: Biopsy Validation of 18F-FDOPA-PET Uptake and Biodistribution in Brain Tumo
Brief Summary:
RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment.
PURPOSE: This clinical trial studies 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
Detailed Summary:
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.
Sponsor: Mayo Clinic
Current Primary Outcome:
- 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies [ Time Frame: Up to 2 years ]Determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.
- 18F- FDOPA-PET metabolic imaging information [ Time Frame: Up to 2 years ]Compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.
Original Primary Outcome:
- Correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies
- Differences in sensitivity and specificity as assessed by McNemar's test
- Comparison of radiotherapy target volume delineation with and without 18F-FDOPA-PET metabolic imaging information
- Biopsy validation of 18F-FDOPA-PET uptake and biodistribution in brain tumors
Current Secondary Outcome:
- Concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies [ Time Frame: Up to 2 years ]Determine correlation between concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival.
- With and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information [ Time Frame: 2 Years ]Compare radiotherapy target volume delineation with and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information; pMRI and DTI advanced MR imaging, to determine role in radiotherapy treatment planning.
- 18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies [ Time Frame: 2 years ]Determine correlation between 18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies.
Original Secondary Outcome: Correlation between concordance of 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall and progression-free survival
Information By: Mayo Clinic
Dates:
Date Received: July 14, 2010
Date Started: July 2010
Date Completion:
Last Updated: October 10, 2016
Last Verified: January 2016