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Sorafenib pharmacokinetics in non small cell lung cancer patients: an in;vivo study using positron emission tomography

Sorafenib pharmacokinetics in non small cell lung cancer patients: an in;vivo study using positron emission tomography - [11C]sorafenib kinetics in NSCLC patients

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37648
Enrollment
12
Registered
2011-12-09
Start date
2012-06-01
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

lung cancer

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patients age of 18-70 years; • Patients with advanced non small cell lung cancer harboring a K-Ras mutation; • 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%; • Laboratory requirements; • Written informed consent

Exclusion criteria

Exclusion criteria: • Claustrophobia; • Pregnant or lactating patients; • Patients having metal implants (e.g. pacemakers); • Concurrent or previous treatment with experimental drugs Anemia

Design outcomes

Primary

MeasureTime frame
[11C]sorafenib pharmacokinetics—

Secondary

MeasureTime frame
1. Comparison of venous versus arterial sampling 2. Reproducibility of [11C]sorafenib PET-CT measurements 3. Relationship between K-Ras mutations and [11C]sorafenib pharmacokinetics in tumor tissue 4. Study the relation between tumor blood flow and [11C]sorafenib uptake in tumors—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)