Clinical Trial: 18F-FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly-Diagnosed or Recurrent Gliomas

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 18F-FDOPA PET/CT or PET/MRI in Patients With Gliomas

Brief Summary: To evaluate 18F-FDOPA PET obtained from PET/CT or PET/MRI imaging in patients with newly diagnosed or recurrent gliomas.

Detailed Summary: This clinical trial compares fluorine F-18 fluoro-dihydroxyphenylalanine (18F-fluorodopa or 18F-FDOPA) positron emission tomography (PET) with standard magnetic resonance imaging (MRI) in measuring tumors in patients with glioma that is newly diagnosed or recurrent (has returned). 18F-FDOPA is a radioactive drug that binds to tumor cells and is captured in images by PET. Computed tomography (CT) and MRI are used with PET to describe information regarding the function, location, and size of the tumor. PET/CT or PET/MRI may be more accurate than standard MRI in helping doctors find and measure brain tumors.
Sponsor: Erik Mittra

Current Primary Outcome:

• Number of Suspicious Lesions Identified by 18F FDOPA PET [ Time Frame: Up to 30 minutes after injection of F18 FDOPA ]
  The number of suspicious lesions will be identified by uptake of F18 FDOPA radiopharmaceutical using a positron emission tomography (PET) scan. Uptake of F-18 FDOPA is a measure of amino acid uptake and metabolism in tumors. Suspicious lesions will be visually identified by a board certified nuclear medicine physician.
• Percent Agreement of 18F FDOPA PET With Pathology [ Time Frame: Up to 30 minutes post-injection (at time of scan) ]
  For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated.

Original Primary Outcome:

• Amount of suspicious lesions identified by 18F FDOPA PET [ Time Frame: Up to 30 minutes post-injection (at time of scan) ]
  The percentage of 18F FDOPA PET positive lesions minus the percentage of conventional imaging positive lesions will be estimated. The significance of the increment will be evaluated by the McNemar test. If the number of lesions per patient allows, nonlinear mixed effects models will be used to evaluate the potential effect of clustering within patient.
• Percent Agreement of 18F FDOPA PET With Pathology [ Time Frame: Up to 30 minutes post-injection (at time of scan) ]
  For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Stanford University

Dates:
Date Received: June 24, 2014
Date Started: December 2014
Date Completion:
Last Updated: January 30, 2017
Last Verified: January 2017