Status:
COMPLETED
FDG-PET Imaging in Young Cystic Fibrosis Patients
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12-21 years
Phase:
NA
Brief Summary
The purpose of this research is to determine how a person's lungs will uptake \[18F\]fluorodeoxyglucose (FDG), as measured with positron emission tomography (PET) scanning in young cystic fibrosis (CF...
Detailed Description
Our recent study in CF adults, supplemented by recent pre-clinical and clinical studies by our group suggests that labeled fluorodeoxyglocose-based positron emission tomography (FDG-PET) imaging may b...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of cystic fibrosis
- Age 12 to 21 years old, of either gender, any race or ethnicity
- Stable recent pulmonary status (defined as no new pulmonary symptoms, new antibiotic use, or hospitalization for pulmonary symptoms for at least 1 month).
- We will permit patients treated with the macrolide antibiotic, azithromycin, to participate in this study. Azithromycin has recently become a virtual standard of care in CF, based on small but reproducible improvements in pulmonary function over 4 months of treatment with this drug. The mechanism of benefit is uncertain, but an anti-inflammatory effect has been suggested. The high prevalence of use means that a study without azithromycin would likely require a wash-out period, without data about the appropriate duration for such a wash-out, or whether inflammatory markers would reverse during that time.
Exclusion
- Failure to obtain informed consent
- Positive pregnancy test or lactation
- Currently enrolled in another study involving radioisotopes or an investigational drug
- Recent (within 30 days of screening) hospitalization for any reason
- New antibiotic use (within 30 days of screening).
- Patient incapable of lying still and supine within the PET/computed X-ray tomography (CT) scanner for 90 minutes.
- Patient incapable of completing other testing procedures (e.g., PFT, induced sputum)
- Patient with serum glucose greater than 150 mg/dl at time of PET imaging study
- Patient incapable of fasting for 4 to 6 hrs prior to PET imaging study
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00846053
Start Date
February 1 2009
End Date
February 1 2012
Last Update
July 24 2018
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110