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FDG-PET Imaging in Young Cystic Fibrosis Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Washington University School of Medicine.
Recruitment status was:  Recruiting
Cystic Fibrosis Foundation Therapeutics
Information provided by:
Washington University School of Medicine Identifier:
First received: February 16, 2009
Last updated: March 2, 2011
Last verified: March 2011
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 patients.

Condition Intervention
Cystic Fibrosis Procedure: [18F]FDG PET/CT

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: FDG-PET Imaging in Young Cystic Fibrosis Patients

Resource links provided by NLM:

Further study details as provided by Washington University School of Medicine:

Estimated Enrollment: 28
Study Start Date: February 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
  • Group S (n = 14) will consist of CF patients, aged 12-21 years old, with stable lung function during the past 4 years, defined as less than 2% decline per year [21,26].
  • Group R (n = 14) will contain CF patients, aged 12-21 years old, with rapidly deteriorating lung function during the past 4 years with greater than 4% per year decline
Procedure: [18F]FDG PET/CT
FDA-approved Investigational New Drug (IND) to use [18F]FDG in CF patients under the age of 18 years (PI: Robert Mach, MD, IND # 76079). Imaging data will be acquired with a Siemens Biograph 40PET/CT Tomograph. Research participants will be positioned supine in the scanner and a scout CT topograph obtained.

Detailed Description:
Our recent study in CF adults, supplemented by recent pre-clinical and clinical studies by our group suggests that 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.

Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Our Pediatric Cystic Fibrosis Clinic currently has 124 patients between the ages of 12 and 21 years. We will need to recruit patients from this clinic population, plus new patients that enter the clinic over the 2 to 3 year period.

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 [36], 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 [36]. 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/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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00846053

Contact: Thomas W Ferkol, MD 314-454-2694
Contact: Mary G Boyle, RN 314-454-4609

United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Thomas W Ferkol, MD    314-454-2694   
Contact: Mary G Boyle, RN, MSN    314-454-4609   
Principal Investigator: Thomas W Ferkol, MD         
Sponsors and Collaborators
Washington University School of Medicine
Cystic Fibrosis Foundation Therapeutics
Principal Investigator: Thomas Ferkol, MD Washington University School of Medicine
  More Information

Responsible Party: Tholmas W. Ferkol, MD, Washington University School of Medicine Identifier: NCT00846053     History of Changes
Other Study ID Numbers: 08-1219
Study First Received: February 16, 2009
Last Updated: March 2, 2011

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017