determining the carbon-11 labelled erlotinib brain uptake in diffuse intrinsic pontine glioma using PET imaging

• Register: EUCTR
• Last refreshed on: 21 May 2018
• Main ID: EUCTR2017-003860-11-NL
• Date of registration: 04/05/2018
• Prospective Registration: Yes
• Primary sponsor: VU University Medical Center
• Public title: determining the carbon-11 labelled erlotinib brain uptake in diffuse intrinsic pontine glioma using PET imaging
• Scientific title: 11C-erlotinib brain uptake in Diffuse Intrinsic Pontine Glioma imaged by PET - 11C-Erlotinib in DIP
• Date of first enrolment: 04/05/2018
• Target sample size: 15
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003860-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Netherlands

Contacts

• Name: F.E. El-Khouly
• Affiliation: VU University Medical Center

• Name: F.E. El-Khouly
• Affiliation: VU University Medical Center

Key inclusion & exclusion 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:
- Known hypersensitivity for erlotinib
- Pregnancy
- Clinically confirmed neurofibromatosis type I


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

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.

Intervention(s)

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
Concentration unit: MBq/µg megabecquerel(s)/microgram
Concentration type: equal
Concentration number: 370-

Primary Outcome(s)

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.

Primary end point(s): Determination of the 11C-erlotinib brain uptake in DIPG patients measured by Tumor-to-Background Ratio (TBR).

Main Objective: Non-invasively determining the 11C-erlotinib brain uptake in DIPG patients by PET imaging.

Secondary Objective: Determining the EGFR expression in DIPG

Secondary Outcome(s)

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.

Secondary end point(s): EGFR expression in patients suffering from DIPG.

Secondary ID(s)

NL60690.029.17

Source(s) of Monetary Support

VU University Medical Center