View Clinical Trial (Medical Research Study)
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 Tumors
| City: |
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Rochester |
| State: |
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Minnesota |
| Zip Code: |
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55905 |
| Conditions: |
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Adult Anaplastic Astrocytoma - Adult Anaplastic Ependymoma - Adult Anaplastic Oligodendroglioma - Adult Brain Stem Glioma - Adult Diffuse Astrocytoma - Adult Ependymoma - Adult Giant Cell Glioblastoma - Adult Glioblastoma - Adult Gliosarcoma - Adult Mixed |
| Purpose: |
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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
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01165632 |
| Primary Contact: |
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Study Chair
Nadia N. Laack, M.D.
Mayo Clinic
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| Backup Contact: |
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N/A |
| Location Contact: |
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Rochester, Minnesota 55905
United States
Mayo Clinic Clinical Trials Office
Phone: 507-538-7623
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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