This study will be performed in children suffering from Diffuse Intrinsic Pontine Glioma (DIPG), who are being treated with erlotinib, and have reached steady state plasma concentrations.
Conditions
Interventions
Trade Name: Erlotinib
Product Name: Erlotinib
Product Code: L01XE03
Pharmaceutical Form: Infusion
INN or Proposed INN: ERLOTINIB
CAS Number: 183321-74-6
Current Sponsor code: EU/1/05/311/001
Concentra
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with MRI confirmed DIPG (histological diagnosis not mandatory) - Erlotinib use for at least 2 week - Age between 4 years and 19 years - Able to lay down quietly for 20 minutes Are the trial subjects under 18? yes Number of subjects for this age range: 15 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Known hypersensitivity for erlotinib - Pregnancy - Clinically confirmed neurofibromatosis type I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Final report with results of this study will be finished within one year after end of the study. ;Main Objective: Non-invasively determining the 11C-erlotinib brain uptake in DIPG patients by PET imaging.;Secondary Objective: Determining the EGFR expression in DIPG;Primary end point(s): Determination of the 11C-erlotinib brain uptake in DIPG patients measured by Tumor-to-Background Ratio (TBR). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): EGFR expression in patients suffering from DIPG.;Timepoint(s) of evaluation of this end point: Final report with results of this study will be finished within one year after end of the study. | — |
Countries
Netherlands
Contacts
Public ContactF.E. El-Khouly
VU University Medical Center
Outcome results
None listed