18FDG-PET Imaging to Detect Changes in Airways Inflammation in Cystic Fibrosis Patients
A Pilot Study of 18FDG-PET Imaging to Detect Changes in Airways Inflammation in Cystic Fibrosis Patients After Treatment for a Pulmonary Exacerbation
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 8, 2008
CompletedFirst Posted
Study publicly available on registry
May 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedOctober 5, 2018
October 1, 2018
2 years
May 8, 2008
October 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in airways inflammation detected by 18FDG -PET from baseline
Measured at end of treatment (day 14)
Secondary Outcomes (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
Measured at end of treatment (day 14)
Study Arms (1)
1
EXPERIMENTALInterventions
The administered intravenous dose of 18-FDG is 0.14mCi/kg up to a maximum of 10mCi before each PET imaging scan is performed.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felix Ratjen, MD
The Hospital for Sick Children
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division Head, Respiratory Medicine
Study Record Dates
First Submitted
May 8, 2008
First Posted
May 26, 2008
Study Start
April 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
October 5, 2018
Record last verified: 2018-10