Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors
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|ClinicalTrials.gov Identifier: NCT01999270|
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : October 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Astrocytoma, Oligoastrocytoma, Mixed Ganglioneuroma Glioma Ganglioglioma Glioblastoma Multiforme Glioma||Drug: Irinotecan Drug: Bevacizumab Device: FDOPA-PET/MRI imaging||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors, A Feasibility Study|
|Study Start Date :||April 2013|
|Primary Completion Date :||May 2016|
|Study Completion Date :||May 2016|
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
- FDOPA-PET/MRI imaging [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999270
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Karen Gauvain, M.D.||Washington University School of Medicine|