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Feasibility study to image [11C]docetaxel kinetics in patients with advanced solid tumors using PET-CT

Feasibility study to image [11C]docetaxel kinetics in patients with advanced solid tumors using PET-CT - [11C]docetaxel kinetics in patients in advanced cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON31382
Enrollment
10
Registered
2007-09-14
Start date
2007-09-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

advanced solid tumors

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patient age of 18-70 years - Patients with advanced cancer planned to receive chemotherapy - Life expectancy of at least 12 weeks - Disease with a malignant lesion of at least 1,5 cm diameter within the chest as measured by Response Evaluation Criteria in Solid Tumors (RECIST) - Performance status Karnofsky index > 60 % - Hemoglobin > 6.0 mmol/l - Written informed consent

Exclusion criteria

Exclusion criteria: - Previous treatment with taxanes - Claustrophobia - Pregnant or lactating patients - Patients having metal implants (e.g. pacemakers) - Due to the fact that docetaxel is a substrate for P-glycoprotein (P-gp), patients using P-gp drugs like digoxin, cyclosporin, amiodarone, steroids, quinidine, colchicine, etoposide, anti-estrogens will be excluded - Use of coumarin derivatives or inhibitors of thrombocyte aggregation - Concurrent treatment with experimental drugs - Participation in a clinical trial with any investigational drug within 30 days prior to study entry

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics of [11C]docetaxel

Secondary

MeasureTime frame
1. Comparison venous versus arterial sampling and comparison of an on-line plasma curve with an IDIF 2. Reproducibility of [11C]docetaxel PET measurements 3. Biodistribution of [11C]docetaxel.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)