[11C]Erlotinib pharmacokinetics: an in vivo study using positron emission tomography 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. - [11C]erlotinib kinetics in NSCLC with and without erlotinib

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36826

Enrollment

Registered

2012-11-12

Start date

2013-10-07

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

lung cancer non-small cell lung carcinoma

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]erloti

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
1) [11C]erlotinib pharmacokinetics with and without erlotinib therapy,	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)