FDG-PET Imaging in Young Cystic Fibrosis Patients

Cystic Fibrosis Clinical Trial

Official title:

FDG-PET Imaging in Young Cystic Fibrosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846053
• Other study ID #: 08-1219
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: February 2012

Study information

• Verified date: June 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Diagnostic Test:
• FDG-PET
All subjects underwent FDG-PET and low-dose volumetric CT imaging. After completing a transmission scan, [18F]FDG was injected intravenously at the start of dynamic scan acquisition. Regions of interest were drawn over multiple tomographic slices to determine average whole-lung and regional lung tissue [18F] FDG uptake. Patlak graphical analysis was used to determine the rate of [18F]FDG uptake from the blood input function and lung tissue activity curves, measured as the influx constant Ki (slope of the linear regression from the Patlak plot). Corrected Ki (i.e., Ki divided by the initial volume of distribution). Lung density was calculated from the attenuation image by standard methods.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Cystic Fibrosis Foundation Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinetic Influx Constant (Ki)	The whole lung kinetic influx constant (Ki) is the primary outcome measure that is derived from the time-activity curves, which are generated from regions of interest placed over the whole lungs. Therefore, a single time-activity curves from each scan is used to derive the Ki.	At the time of FDG scan, 1 to 2 hours
Secondary	Sputum Neutrophil Elastase (NE) Concentration	Using established techniques, functional activity of neutrophil elastase in sputum sols were measured using methoxy-succinyl-ala-ala-pro-val-nitroanilide (Elastin Products, Owensville, MO), specific peptide chromogenic substrates of the neutrophil protease	Sample collected within 2-hours of PET scan