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

Tracking Information

First Received Date ^ICMJE

May 8, 2008

Last Updated Date

December 7, 2010

Start Date ^ICMJE

April 2008

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00684346 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Pilot Study of 18FDG-PET Imaging to Detect Changes in Airways Inflammation in Cystic Fibrosis Patients After Treatment for a Pulmonary Exacerbation

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.

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Cystic Fibrosis

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: 1

Intervention: Other: 18-FDG

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00684346

Other Study ID Numbers ^ICMJE

1000011762

Has Data Monitoring Committee

Responsible Party

Felix Ratjen/Principal Investigator, The Hospital for Sick Children

Study Sponsor ^ICMJE

The Hospital for Sick Children

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Felix Ratjen, MD

The Hospital for Sick Children

Information Provided By

The Hospital for Sick Children

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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