N/A
N=21
FDG-PET Imaging in Young Cystic Fibrosis Patients
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00846053 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Kinetic Influx Constant (Ki) — 0.009; 0.013 mL/min/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FDG-PET (Diagnostic_test)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kinetic Influx Constant (Ki) |
0.009; 0.013 | — |
| SECONDARY Sputum Neutrophil Elastase (NE) Concentration |
2179; 1656 | — |
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) patients.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00846053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.