Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors
Astrocytoma, Oligoastrocytoma, Mixed
Glioblastoma Multiforme Glioma
Device: FDOPA-PET/MRI imaging
|Study Design:||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:||January 2017 (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
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: Robert McKinstry, M.D.|
|Sub-Investigator: Robert Hayashi, M.D.|
|Principal Investigator:||Karen Gauvain, M.D.||Washington University School of Medicine|