FDG-PET Imaging in Young Cystic Fibrosis Patients

Completed · Not applicable

Conditions studied: Cystic Fibrosis

In brief

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) patients.

Key facts

Study ID

NCT00846053

Run by

Washington University School of Medicine

People needed

21

Starts

2009-02-01

Expected to finish

2012-02-01

Last updated by the study team

2018-07-24

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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