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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684346
• Other study ID #: 1000011762
• Status: Completed
• Phase: Phase 3
• Start date: April 2008
• Est. completion date: April 2010

Study information

• Verified date: October 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Inflammation

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in airways inflammation detected by 18FDG -PET from baseline		Measured at end of treatment (day 14)
Secondary	Correlation of pre and post 18FDG-PET data with lung function (FEV1, FEF 25-75 and FVC), sputum neutrophil count and sputum free elastase		Measured at end of treatment (day 14)

External Links

•   Link to published study results