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

This study has been completed.
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00684346
First received: May 8, 2008
Last updated: December 7, 2010
Last verified: December 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

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 ]

Enrollment: 20
Study Start Date: April 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Felix Ratjen, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Felix Ratjen/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00684346     History of Changes
Other Study ID Numbers: 1000011762
Study First Received: May 8, 2008
Last Updated: December 7, 2010
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
18FDG-PET imaging
airway inflammation
cystic fibrosis
pediatric
pulmonary exacerbation

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Inflammation
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013