FDG-PET Imaging in Young Cystic Fibrosis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00846053
First received: February 16, 2009
Last updated: March 2, 2011
Last verified: March 2011
  Purpose

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
2
  • 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.
Other Name: [18F]FDG PET/CT

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.

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
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.

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 [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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846053

Contacts
Contact: Thomas W Ferkol, MD 314-454-2694 ferkol_t@wustl.edu
Contact: Mary G Boyle, RN 314-454-4609 boyle@kids.wustl.edu

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

No publications provided

Responsible Party: Tholmas W. Ferkol, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00846053     History of Changes
Other Study ID Numbers: 08-1219
Study First Received: February 16, 2009
Last Updated: March 2, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014