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Reproducibility of FDG PET scans in patients with lung cancer.


- candidate number13104
- NTR NumberNTR3508
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jul-2012
- Secondary IDs2012/148 METC VUmc
- Public TitleReproducibility of FDG PET scans in patients with lung cancer.
- Scientific TitleTest-retest reproducibility of whole body [18F]FDG PET-CT in patients with non-small cell lung cancer.
- ACRONYMFDG reproducibility
- hypothesisReproducible test-retest assessment of [18F]FDG PET.
- Healt Condition(s) or Problem(s) studiedNon small cell lung cancer (NSCLC), Reproducibility, FDG-PET
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2012
- planned closingdate1-aug-2013
- Target number of participants12
- Interventions[18F]FDG PET at two seperate timepoints.
- Primary outcomeReproducibility 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 outcomeTo evaluate reproducibility of the variables as a function of the [18F]FDG time uptake interval.
- TimepointsTaken together we expect to complete the patient inclusion in 6 months; data analysis and writing will require approximately 3 months.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. R. Boellaard
- CONTACT for SCIENTIFIC QUERIES O.S. Hoekstra
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryRationale:
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.

Objective:
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.

Study design:
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).

Study population:
Patients with histological proven NSCLC, stage IIIB or IV.

Intervention:
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.

Study time-course:
We expect to complete the patient inclusion in 6 months; data analysis and writing will require 3 months.

Statistical analysis:
Intraclass correlations and Bland-Altman analysis will be performed to evaluate reproducibility between the two scans.
- Main changes (audit trail)
- RECORD5-jul-2012 - 23-jul-2012


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