search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


FLT PET in patienten met niet kleincellig long carcinoom behandeld met gefitinib.


- candidate number13195
- NTR NumberNTR3557
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-aug-2012
- Secondary IDs12/172 METc VUmc
- Public TitleFLT PET in patienten met niet kleincellig long carcinoom behandeld met gefitinib.
- Scientific TitleValidation of simplified quantitative [18F]FLT PET methods in NSCLC patients treated with gefitinib.
- ACRONYM
- hypothesisSimplified FLT PET parameter.
- Healt Condition(s) or Problem(s) studiedNon small cell lung cancer (NSCLC)
- Inclusion criteria1. 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 criteria1. Pregnant or lactating patients;
2. Metal implants (e.g. pacemakers);
3. Body weight > 100 kg.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2012
- planned closingdate1-sep-2013
- Target number of participants10
- Interventions[15O]H2O and [18F]FLT PET scan at 3 different timepoints.
- Primary outcomeThe 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 outcomeSecondary, nonlinear kinetic filtering will be evaluated and perfusion measured with [15O]H2O PET.
- TimepointsBaseline, and 7 and 28 days after start of treatment.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES O.S. Hoekstra
- CONTACT for SCIENTIFIC QUERIES O.S. Hoekstra
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
IMI
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD2-aug-2012 - 2-feb-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl