No registrations found.
ID
Source
Health condition
NSCLC
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study parameters are the results of the simplified measures and the pharmacokinetic modeling of [18F]FLT PET prior to therapy and during treatment with gefitinib.
Secondary outcome
Secondary, nonlinear kinetic filtering will be evaluated and perfusion measured with [15O]H2O PET.
Background summary
The aim of the present study is to validate simplified quantitative methods for [18F]FLT PET in patients with non-small cell lung cancer (NSCLC) treated with gefitinib.
It is monocenter, prospective observational study including 10 patients with NSCLC who will be scanned with [15O]H2O and [18F]FLT PET on three separate occasions: within 7 days prior to treatment, and 7 and 28 days after the first therapeutic dose of gefitinib, respectively. Full kinetic analysis will be performed.
Study objective
Simplified FLT PET parameter.
Study design
Baseline, and 7 and 28 days after start of treatment.
Intervention
[15O]H2O and [18F]FLT PET scan at 3 different timepoints.
O.S. Hoekstra
Amsterdam 1007 MB
The Netherlands
O.S. Hoekstra
Amsterdam 1007 MB
The Netherlands
Inclusion criteria
1. Patient age 18 years or older;
2. Histological diagnosis of NSCLC;
3. Active EGFR-TK mutation;
4. Scheduled for treatment with gefitinib;
5. Tumour diameter > 3cm (to minimize partial volume effects) within the chest;
6. Able to remain supine for 90 minutes in the PET-CT scanner;
7. Written informed consent.
Exclusion criteria
1. Pregnant or lactating patients;
2. Metal implants (e.g. pacemakers);
3. Body weight > 100 kg.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL3386 |
| NTR-old | NTR3557 |
| Other | METc VUmc : 12/172 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |