[11C]Erlotinib pharmacokinetics may be comparable between non-small cell lung cancer patients with and without erlotinib therapy.
ID
Bron
Aandoening
Non-small cell lung cancer
NSCLC
Niet-kleincellig longkanker
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To compare tumor [11C]erlotinib pharmacokinetics in NSCLC patients with and without erlotinib therapy.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
[11C]Erlotinib pharmacokinetics may be comparable between non-small cell lung cancer patients with and without erlotinib therapy.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
[default]
The Netherlands
Wetenschappelijk
[default]
The Netherlands
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3508 |
| NTR-old | NTR3670 |
| Ander register | CCMO : 2012-004475-39 / NL41138.029.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |