No registrations found.
ID
Source
Health condition
Non-small cell lung cancer
NSCLC
Niet-kleincellig longkanker
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare tumor [11C]erlotinib pharmacokinetics in NSCLC patients with and without erlotinib therapy.
Secondary outcome
Also, to assess the relationship of venous sampling versus arterial, of tumor [11C]erlotinib uptake and blood flow with and without therapy, and to explore the usefulness of static whole body images. Also, to validate image derived input function (IDIF) against continuous arterial sampling.
Background summary
N/A
Study objective
[11C]Erlotinib pharmacokinetics may be comparable between non-small cell lung cancer patients with and without erlotinib therapy.
Study design
N/A
Intervention
The procedure consists of a low dose CT scan, intravenous administration of [15O]H2O and 15-minutes [15O]H2O PET scan, followed by another low dose CT scan, intravenous administration of [11C]erlotinib and PET acquisition for about one hour with arterial and venous blood sampling during [11C]erlotinib PET scanning. The first 2 patients will also undergo continuous arterial sampling during [11C]erlotinib PET. To compare tumor [11C]erlotinib uptake with and without erlotinib therapy, this scanning sequence will be performed prior to therapy and 1 week after start of therapy. A tumor biopsy will be taken before PET scanning.
[default]
The Netherlands
[default]
The Netherlands
Inclusion criteria
Patients with NSCLC, planned to receive erlotinib for therapy will be included in this study. Ten evaluable patients are needed. It is expected that this number of patients will be recruited within 1 year.
1. Patients age: Between 18 and 70 years;
2. Life expectancy of at least 12 weeks;
3. Malignant lesion of at least 1.5 cm diameter within the chest as measured by CT;
4. Performance status Karnofsky index >60%;
5. Written informed consent.
Exclusion criteria
1. Claustrophobia;
2. Pregnant or lactating patients;
3. Metal implants in the thorax (e.g. pacemakers), interfering with PET/CT imaging;
4. Concurrent treatment with experimental drugs.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3508 |
| NTR-old | NTR3670 |
| Other | CCMO : 2012-004475-39 / NL41138.029.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |