FDG-PET Imaging in Young Cystic Fibrosis Patients

The Washington University

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Diagnostic Test: FDG-PET

Study type: Interventional

Funder types: Other

Identifiers

NCT00846053

08-1219

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Stable lung function

Other group

Description:

\* Group S (n = 14) will consist of CF patients, aged 12-21 years old, who underwent FDG-PET with stable lung function during the past 4 years, defined as less than 2% decline per year. There is no therapeutic intervention and FDG-PET scan will be performed in both cohorts.

Treatment:

Diagnostic Test: FDG-PET

Rapidly deteriorating lung function

Other group

Description:

\* Group R (n = 14) will contain CF patients, aged 12-21 years old, who underwent FDG-PET with rapidly deteriorating lung function during the past 4 years with greater than 4% per year decline. There is no therapeutic intervention and FDG-PET scan will be performed in both cohorts.

Treatment:

Diagnostic Test: FDG-PET