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

[11C]Erlotinib pharmacokinetics: an in vivo study using positron emission tomography in non-small cell lung cancer patients with and without erlotinib therapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28948
Enrollment
10
Registered
2012-10-19
Start date
2013-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer NSCLC Niet-kleincellig longkanker

Interventions

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]erlotini

Sponsors

VU University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
To compare tumor [11C]erlotinib pharmacokinetics in NSCLC patients with and without erlotinib therapy.

Secondary

MeasureTime frame
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.

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)