To compare tumor [11C]erlotinib pharmacokinetics in NSCLC patients with and without erlotinib therapy. Also, to assess the relationship of venous sampling versus arterial, of tumor [11C]erlotinib uptake and blood flow with and without therapy, and…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) [11C]erlotinib pharmacokinetics with and without erlotinib therapy,
Secondary outcome
2) comparison of venous versus arterial sampling for correcting pharmacokinetic
input curves,
3) relationship between [11C]erlotinib pharmacokinetics in tumor tissue and
tumor blood flow with and without erlotinib therapy,
4) assessing the correlation between uptake parameters from dynamic PET scans
and static whole body scans, obtained by reconstructing the available dynamic
PET data.
5) Validate IDIF against continuous arterial sampling.
Background summary
We previously labeled erlotinib, an EGFR TKI, with the positron emitter C-11,
and showed in a positron emission tomography (PET) study that [11C]erlotinib
accumulation in TKI-naïve non-small cell lung cancer (NSCLC) tumors could be
quantified. [11C]erlotinib was shown to be correlate with EGFR mutational
status and tumor response to erlotinib therapy. To use this technique in
patients who are being treated with erlotinib, but may be developing
progression, we need to validate the previous results in patients with and
without erlotinib therapy.
Study objective
To compare tumor [11C]erlotinib pharmacokinetics in NSCLC patients with and
without erlotinib therapy. 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.
Study design
An observational study with invasive measurements.
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.
Study burden and risks
The total amount of blood withdrawn will be no more than 270 mL for the first 2
patients and no more than 200 mL (7mLx7x2x2) for the rest of the patients,
including both test and retest procedures. The total amount of radiation
burden: 7 mSv.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Patients with NSCLC, planned to receive erlotinib for therapy will be included in this study.
Patients age: between 18 and 70 years
Life expectancy of at least 12 weeks
Malignant lesion of at least 1.5 cm diameter within the chest as measured by CT
Performance status Karnofsky index >60%
Written informed consent
Exclusion criteria
Claustrophobia
Pregnant or lactating patients
Metal implants in the thorax (e.g. pacemakers), interfering with PET/CT imaging
Concurrent treatment with experimental drugs
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2012-004475-39-NL |
| CCMO | NL41138.029.12 |