18FDG-PET Imaging to Detect Changes in Airways Inflammation in Cystic Fibrosis Patients - Full Text View

Sponsored by:	The Hospital for Sick Children
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00684346

Purpose

The purpose of this study is to determine if 18Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging can detect changes in airways inflammation in Cystic Fibrosis (CF) patients after treatment for a pulmonary exacerbation.

Condition	Intervention	Phase
Cystic Fibrosis	Other: 18-FDG	Phase III

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Fluorodeoxyglucose F18

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Pilot Study of 18FDG-PET Imaging to Detect Changes in Airways Inflammation in Cystic Fibrosis Patients After Treatment for a Pulmonary Exacerbation

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

Change in airways inflammation detected by 18FDG -PET from baseline [ Time Frame: Measured at end of treatment (day 14) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation of pre and post 18FDG-PET data with lung function (FEV1, FEF 25-75 and FVC), sputum neutrophil count and sputum free elastase [ Time Frame: Measured at end of treatment (day 14) ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	April 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Other: 18-FDG The administered intravenous dose of 18-FDG is 0.14mCi/kg up to a maximum of 10mCi before each PET imaging scan is performed.

Detailed Description:

Neutrophils play a key role in the pathogenesis of CF lung disease. We know that neutrophilic inflammation is related to a decline in pulmonary function. Therefore, early anti-inflammatory intervention is an opportunity to slow this irreversible pulmonary destruction. However, the development of sensitive, non-invasive diagnostic tools of airways inflammation is essential to the study and implementation of anti-inflammatory therapies. Our current armentarium of measures of airways inflammation is limited. BAL is invasive and not clinically acceptable as a tool for the serial measurement of inflammation. Sputum samples are highly variable and not reliable.

18FDG-PET is a promising tool because it is non invasive, has been shown to quantify the amount and location of neutrophilic inflammation and has the potential to be used to track inflammation over time. Therefore, the goal of this research study is to evaluate the ability of 18FDG -PET imaging to detect changes in airways inflammation in CF patients in response to conventional treatment for a pulmonary exacerbation

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride > 60mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
Informed consent and verbal assent (as appropriate) provided by the subject's parent or legal guardian and the subject
Ages 6-18 and able to perform reproducible spirometry
Admission to the Hospital for Sick Children for a pulmonary exacerbation

Exclusion Criteria:

Inability to perform reproducible spirometry
Diagnosis of Cystic Fibrosis Related Diabetes (CFRD)
Medical instability that would preclude the ability to perform PET imaging
FEV1% predicted < 40%
The use of supplementary oxygen
Pregnancy or breastfeeding
Severe claustrophobia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684346

Locations

Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada
Contact: Felix Ratjen, MD 416-813-6167 felix.ratjen@sickkids.ca
Principal Investigator: Felix Ratjen, MD
Sub-Investigator: Martin Charron, MD
Sub-Investigator: Reshma Amin, MD

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

Principal Investigator:

Felix Ratjen, MD

The Hospital for Sick Children

More Information

Responsible Party:	The Hospital for Sick Children ( Felix Ratjen/Principal Investigator )
Study ID Numbers:	1000011762
Study First Received:	May 8, 2008
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00684346
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:

18FDG-PET imaging
airway inflammation
cystic fibrosis
pediatric
pulmonary exacerbation

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
Inflammation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009