|- candidate number||13104|
|- NTR Number||NTR3508|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-jul-2012|
|- Secondary IDs||2012/148 METC VUmc|
|- Public Title||Reproducibility of FDG PET scans in patients with lung cancer.|
|- Scientific Title||Test-retest reproducibility of whole body [18F]FDG PET-CT in patients with non-small cell lung cancer.|
|- ACRONYM||FDG reproducibility|
|- hypothesis||Reproducible test-retest assessment of [18F]FDG PET.|
|- Healt Condition(s) or Problem(s) studied||Non small cell lung cancer (NSCLC), Reproducibility, FDG-PET|
|- Inclusion criteria||1. Patient age 18 years or older;|
2. Histological diagnosis of NSCLC, stage IIIB or IV;
3. At least one tumour with diameter > 3cm (to minimize partial volume effects);
4. Able to remain supine for 60 minutes in the PET-CT scanner;
5. Written informed consent.
|- Exclusion criteria||1. Chemotherapy in the past 4 weeks;|
2. Pregnant or lactating patients;
3. Metal implants (e.g. pacemakers);
4. Weight of more than 100 kg;
5. Known diabetes mellitus type I and II.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-aug-2012|
|- planned closingdate||1-aug-2013|
|- Target number of participants||12|
|- Interventions||[18F]FDG PET at two seperate timepoints.|
|- Primary outcome||Reproducibility of various SUV measures, metabolic and anatomic volume measurements on whole body [18F]FDG PET-CT. Test-retest variability will be calculated and expressed in terms of intraclass correlations and Bland-Altman analysis. Two-sided paired t-test and correlation analysis will be performed to asses the significance of any differences in the outcome measurements (SUV and volume).|
|- Secondary outcome||To evaluate reproducibility of the variables as a function of the [18F]FDG time uptake interval. |
|- Timepoints||Taken together we expect to complete the patient inclusion in 6 months; data analysis and writing will require approximately 3 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. R. Boellaard|
|- CONTACT for SCIENTIFIC QUERIES|| O.S. Hoekstra|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|VU University Medical Center|
|- Brief summary||Rationale: |
To detect changes in multiple [18F]fluorodeoxyglucose positron emission tomography – computed tomography ([18F]FDG PET-CT) scans in one patient, test-retest variability needs to be determined, to know when an observed difference is due to a true biological effect.
The aim of the present study is to further measure the test-retest reproducibility of [18F]FDG PET-CT whole body scans in non-small cell lung cancer (NSCLC) patients. In this study the impact of using different tracer uptake periods and use of state of the art PET-CT technology of tracer uptake quantification and delineation using various new methodologies will be explored. Moreover, test-retest variability of 1D, 2D and volumetric tumor size measurements will be assessed.
Monocentre, prospective observational study including 12 eligible patients with NSCLC who will be scanned with [18F]FDG on two separate occasions (within one week), without intervening therapy. Personal characteristics will be registered (age, sex, bodyweight, height).
Patients with histological proven NSCLC, stage IIIB or IV.
The procedure consists of intravenous administration of [18F]FDG and PET-CT scanning. This procedure will be repeated within a maximum of 7 days (test-retest design).
Main study parameters/endpoints:
Reproducibility of standardized uptake value (SUV), metabolic and anatomic volume measurements on whole body [18F]FDG PET-CT.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The total amount of radiation burden is 26 mSv.
We expect to complete the patient inclusion in 6 months; data analysis and writing will require 3 months.
Intraclass correlations and Bland-Altman analysis will be performed to evaluate reproducibility between the two scans.
|- Main changes (audit trail)|
|- RECORD||5-jul-2012 - 23-jul-2012|