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Trials / Completed

CompletedNCT01999270

Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors

Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors, A Feasibility Study

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
6 (actual)
Sponsor
Washington University School of Medicine · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

Summary

To determine if FDOPA-PET/MRI imaging can predict response to treatment of bevacizumab.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGIrinotecanIrinotecan 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.
DRUGBevacizumabBevacizumab 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.
DEVICEFDOPA-PET/MRI imagingFDOPA-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

Timeline

Start date
2013-04-01
Primary completion
2016-05-01
Completion
2016-05-01
First posted
2013-12-03
Last updated
2016-10-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01999270. Inclusion in this directory is not an endorsement.