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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

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

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

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

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:
Astrocytoma
Genes 27
TSC2 APC MSH3 BRCA2 MLH1 TSC1 PMS2 APC IDH1 MSH6 POT1 TSC2 CDKN2A NF2 IFNG MSH3 APC TSC1 NF1 APC TP53 MSH2 ERBB2 IDH1 APC IDH2 NF2
Ganglioneuroma
Genes 16
ASCL1 PHOX2B PHOX2B GDNF GDNF BDNF PHOX2B PHOX2B KIF1B RET EDN3 RET EDN3 MYO1H ASCL1 RET
Glioblastoma multiforme
Genes 23
FAN1 APC BMPR1A KRAS BRCA2 RPS20 MLH1 MSH2 MSH6 EPCAM PMS2 MLH1 MLH3 PMS2 PMS1 MSH6 TP53 MSH2 TGFBR2 PIK3CA SEMA4A ERBB2 IDH1
Glioma
Genes 50
TSC2 GLI3 BRCA2 TSC1 LRP5 MLH1 PMS2 APC IDH1 MSH6 POT1 TSC2 CDKN2A NF2 MSH3 MSH6 APC NF1 EPCAM TSC1 TGFBR2 SEMA4A IDH1 IDH2 FAN1 APC MSH3 BMPR1A KRAS MLH1 MSH2 C11ORF95 PMS2 MLH3 PIK3CA NBN RELA SETBP1 IFNG RPS20 NF1 PMS1 CHEK2 APC TP53 MSH2 NBN ERBB2 APC NF2
Subependymal giant-cell astrocytoma
Genes 2
TSC1 TSC2