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Report for Clinical Trial NCT01999270

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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

NCT01999270 Astrocytoma, Oligoastrocytoma, Mixed Ganglioneuroma Glioma Ganglioglioma Glioblastoma Multiforme Glioma
MeSH:Glioblastoma Glioma Astrocytoma Ganglioglioma Ganglioneuroma
HPO:Astrocytoma Ganglioneuroma Glioblastoma multiforme Glioma Subependymal giant-cell astrocytoma

3 Interventions

Name: Irinotecan

Description: 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.
Type: Drug
Group Labels: 1

Irinotecan, Bevacizumab and FDOPA-PET/MRI imaging

Name: Bevacizumab

Description: 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.
Type: Drug
Group Labels: 1

Irinotecan, Bevacizumab and FDOPA-PET/MRI imaging

Name: FDOPA-PET/MRI imaging

Description: 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
Type: Device
Group Labels: 1

Irinotecan, Bevacizumab and FDOPA-PET/MRI imaging


Primary Outcomes

Description: 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.

Measure: FDOPA-PET/MRI imaging

Time: 1 year

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 G20210A

- Patient must not have a known thrombophilic condition (i.e. protein S, protein C or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia, or antiphospholipid antibody syndrome). --- G20210A ---



HPO Nodes


HPO: