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

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. Identifier: NCT00684346
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : September 2, 2013
Information provided by (Responsible Party):
Felix Ratjen, The Hospital for Sick Children

Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Other: 18-FDG Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Change in airways inflammation detected by 18FDG -PET from baseline [ Time Frame: Measured at end of treatment (day 14) ]

Secondary Outcome Measures :
  1. 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) ]

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00684346

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Felix Ratjen, MD The Hospital for Sick Children

Responsible Party: Felix Ratjen, Division Head, Respiratory Medicine, The Hospital for Sick Children Identifier: NCT00684346     History of Changes
Other Study ID Numbers: 1000011762
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013

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

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action