Clinical trial NCT00846053: FDG-PET Imaging in Young Cystic Fibrosis Patients
Official title: FDG-PET Imaging in Young Cystic Fibrosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2009-02-18
Enrollment: 21
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: In this pilot study, we examined the value of FDG-PET scans as a noninvasive measure of neutrophilic inflammation in adolescents and young adults with cystic fibrosis. All subjects underwent scans.
Primary purpose: DIAGNOSTIC

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) patients.

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 be a valuable quantitative biomarker of lung inflammation. The proposed study would validate our earlier findings, but in a younger patient population. The implications of such a test could be highly significant for both the testing of promising new anti-inflammatory agents and for patient management decisions. To capitalize on this exciting opportunity, the critical next step is to show that we can identify a cohort of young CF patients with both stable lung function and normal (or near normal) FDG-PET imaging studies. Similar patients, then, would become the subjects for a future prospective cohort study to determine if FDG-PET imaging can in fact serve as a predictor of future changes in lung function.

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

Primary outcomes:
measure: Kinetic Influx Constant (Ki)
timeFrame: At the time of FDG scan, 1 to 2 hours
Secondary outcomes:
measure: Sputum Neutrophil Elastase (NE) Concentration
timeFrame: Sample collected within 2-hours of PET scan
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Thomas Ferkol, MD
role: PRINCIPAL_INVESTIGATOR
References: