18FDG- PET/CT Contribution to the Assessment of Lesion Severity in Cystic Fibrosis (CF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00363402|
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : May 20, 2009
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Procedure: PET-CT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||18FDG- PET/CT Contribution to the Assessment of Lesion Severity in Cystic Fibrosis (CF|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||December 2007|
- Improved diagnosis of CF patients
- Real-time follow up of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363402
|Hadassah Medical Organization|
|Jerusalem, Israel, 24035|
|Study Director:||Eitan Kerem, MD||Hadassah Medical Organization|