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18FDG- PET/CT Contribution to the Assessment of Lesion Severity in Cystic Fibrosis (CF)

This study is currently recruiting participants.
Verified by Hadassah Medical Organization, August 2006

Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00363402
  Purpose

Cystic fibrosis (CF) is an autosomal recessive disorder caused by mutations in the CF trans-membrane conductance regulator (CFTR) protein. CF is the most common inherited disease of Caucasians, with a carrier frequency of 1 in 25-30 individuals. Even with the impressive advances achieved in the understanding of the molecular basis and physiopathology of CF, it remains a life-threatening disorder that causes severe lung damage and nutritional deficiencies. It is generally accepted that early therapy could delay the progression of lung disease. A number of non-invasive methods are available to monitor disease activity in CF patients; however none of the currently used tools are able to monitor real-time events. Recently high resolution computed tomography (HRCT) has been used to monitor changes in lung structure. However, HRCT does not allow differentiating between acute and chronic lesions. Positron emission tomography (PET) with 18fluoro-deoxy-glucose (FDG) has already been used in a variety of settings to visualize inflammation or infection. FDG-PET imaging appears to be a promising new tool to quantify inflammation as it can detect clinically relevant changes even when no changes or minimal ones are detected by morphologic imaging. PET/CT may consequently be used to evaluate the severity of lung inflammation/infection in CF patients, and therefore the aim of this study is to evaluate the use of PET/CT for the assessment of the severity of lung inflammation/ infection in CF patients.


Condition Intervention
Cystic Fibrosis
Procedure: PET-CT

Genetics Home Reference related topics:   cystic fibrosis   

MedlinePlus related topics:   Cystic Fibrosis   

ChemIDplus related topics:   Fluorodeoxyglucose F18   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   18FDG- PET/CT Contribution to the Assessment of Lesion Severity in Cystic Fibrosis (CF

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Improved diagnosis of CF patients
  • Real-time follow up of treatment

Estimated Enrollment:   20
Study Start Date:   August 2006
Estimated Study Completion Date:   December 2007

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:CF patients with active lesions in their lungs -

Exclusion Criteria:pregnancy,

-

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363402

Contacts
Contact: Eitan Kerem, MD     927-2-584 4430     kerem@hadassah.org.il    
Contact: Hadas Lemberg, PhD     972-2-6777 572     lhadas@hadassah.org.il    

Locations
Israel
Hadassah Medical Organization     Recruiting
      Jerusalem, Israel, 24035
      Contact: Eitan Kerem, MD     972-2-5844 430     kerem@hadassah.oerg.il    
      Contact: Hadas Lemberg, PhD     972 2 6777572     lhadas@hadassah.org.il    
      Sub-Investigator: Malena Cohen-Cymberknoh, MD            
      Sub-Investigator: Martine Klein, MD            
      Sub-Investigator: David Shoseyov, MD            

Sponsors and Collaborators
Hadassah Medical Organization

Investigators
Study Director:     Eitan Kerem, MD     Hadassah Medical Organization    
  More Information


Study ID Numbers:   PETCT-HMO-CTIL
First Received:   August 10, 2006
Last Updated:   April 10, 2007
ClinicalTrials.gov Identifier:   NCT00363402
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Cystic Fibrosis  

Study placed in the following topic categories:
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on October 10, 2008




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