Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors
To determine if FDOPA-PET/MRI imaging can predict response to treatment of bevacizumab.
Astrocytoma, Oligoastrocytoma, Mixed
Glioblastoma Multiforme Glioma
Device: FDOPA-PET/MRI imaging
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors, A Feasibility Study|
- FDOPA-PET/MRI imaging [ Time Frame: 1 year ] [ Designated as safety issue: No ]The imaging is evaluated: (a) the uptake of PET tracer FDOPA measured by average and maximal standardized uptake values (SUVs) as well as tumor to normal brain ratios; and (b) tumor volumes defined by MRI signal abnormality.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||April 2019|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Irinotecan, Bevacizumab and FDOPA-PET/MRI imaging
Irinotecan can be removed from the treatment plan at the discretion of the healthcare provider.
Irinotecan IV over 90 minutes on Days 1, 15, and 29 of each cycle (except Cycle 1, when it will be started on Day 29)
Note: Irinotecan can be removed from the treatment plan at the discretion of the healthcare provider.
Other Names:Drug: Bevacizumab
Bevacizumab will be given intravenously AFTER the irinotecan infusion is complete on Days 1, 15, and 29 of each cycle. The first dose will be given over 90 minutes, but doses after that may be given over 30-60 minutes.
Other Name: Avastin®Device: FDOPA-PET/MRI imaging
FDOPA-PET/MRI imaging Baseline (before beginning Cycle 1 treatment) Cycle 1, Day 29 (before receiving your treatment with bevacizumab) and end of treatment or time of relapse
Evaluate the feasibility of using FDOPA-PET/MRI pediatric patients with CNS tumors. Positive results in this small study would provide the data needed to expand the study to validate the use in a larger population of pediatric patients. Validating the use of FDOPA-PET imaging as an early predictor for response to anti-angiogenic therapy could greatly impact the standard of care for treating and evaluating pediatric brain tumors and provide a useful biomarker for assessing experimental therapeutics.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01999270
|Contact: Karen Gauvain, M.D.||314-286-2790||Gauvain_K@kids.wustl.edu|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Contact: Karen Gauvain, M.D. 314-286-2790 Gauvain_K@kids.wustl.edu|
|Sub-Investigator: Jonathan McConathy, M.D., Ph.D.|
|Sub-Investigator: Joshua Rubin, M.D., Ph.D|
|Sub-Investigator: Jeffrey Leonard, M.D.|
|Sub-Investigator: Robert McKinstry, M.D.|
|Sub-Investigator: Robert Hayashi, M.D.|
|Sub-Investigator: Amy Barone, M.D.|
|Principal Investigator:||Karen Gauvain, M.D.||Washington University School of Medicine|