Reproducible test-retest assessment of [18F]FDG PET.
ID
Bron
Verkorte titel
Aandoening
NSCLC
Reproducibility
FDG PET
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
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.
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.
Doel van het onderzoek
Reproducible test-retest assessment of [18F]FDG PET.
Onderzoeksopzet
Taken together we expect to complete the patient inclusion in 6 months; data analysis and writing will require approximately 3 months.
Onderzoeksproduct en/of interventie
[18F]FDG PET at two seperate timepoints.
Publiek
VU University medical centre (VUmc)<br>
P.O. Box 7057
R. Boellaard
Amsterdam 1007 MB
The Netherlands
Wetenschappelijk
VU University medical centre (VUmc)<br>
P.O. Box 7057
R. Boellaard
Amsterdam 1007 MB
The Netherlands
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3360 |
| NTR-old | NTR3508 |
| Ander register | METC VUmc : 2012/148 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |