18FDG- PET/CT Contribution to the Assessment of Lesion Severity in Cystic Fibrosis (CF)
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
|Official Title:||18FDG- PET/CT Contribution to the Assessment of Lesion Severity in Cystic Fibrosis (CF|
- Improved diagnosis of CF patients
- Real-time follow up of treatment
|Study Start Date:||August 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Cystic fibrosis patients with active lung disease will undergo a high resolution PET-CT.PET/CT scans (GE ST Discovery PET/CT scanner) will be performed 60 to 90 minutes after injection of 5 MBq/kg of FDG. PET/CT will be repeated at the end of the treatment and compared with the results of the initial scan. PET and CT will be interpreted by a certified nuclear medicine physician and by a certified radiologist, respectively, blinded to clinical data, using the PET severity score (PSS), based on the number and the intensity of FDG uptake of lung foci. Intensity of uptake will be determined by calculating the mean value for the maximum standardized uptake values (MSUV) of all foci.
(SUV = Activity concentration in ROI (region of interest) divided by injected dose / patient body weight). SUV will be measured in normal lungs to receive the normal baseline control for the calculations. The correlation with clinical data (FEV1% predicted) and sputum bacteriology will then be performed. Inflammation status will also be followed by cytokine analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00363402
|Hadassah Medical Organization|
|Jerusalem, Israel, 24035|
|Study Director:||Eitan Kerem, MD||Hadassah Medical Organization|