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[11C]Erlotinib in non-small cell lung cancer patients with and without erlotinib therapy.


- candidate number13456
- NTR NumberNTR3670
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-okt-2012
- Secondary IDs2012-004475-39 / NL41138.029.12 CCMO
- Public Title[11C]Erlotinib in non-small cell lung cancer patients with and without erlotinib therapy.
- Scientific Title[11C]Erlotinib pharmacokinetics: an in vivo study using positron emission tomography in non-small cell lung cancer patients with and without erlotinib therapy.
- ACRONYM
- hypothesis[11C]Erlotinib pharmacokinetics may be comparable between non-small cell lung cancer patients with and without erlotinib therapy.
- Healt Condition(s) or Problem(s) studiedNon small cell lung cancer (NSCLC)
- Inclusion criteriaPatients 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate31-dec-2013
- Target number of participants10
- InterventionsThe 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.
- Primary outcomeTo compare tumor [11C]erlotinib pharmacokinetics in NSCLC patients with and without erlotinib therapy.
- Secondary outcomeAlso, 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.
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD19-okt-2012 - 10-nov-2012


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