Expired Study
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Rochester, Minnesota 55905


Purpose:

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


Study 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.


Criteria:

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


NCT ID:

NCT01165632


Primary Contact:

Study Chair
Nadia N. Laack, M.D.
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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