FDG-PET Imaging in Young Cystic Fibrosis Patients
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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 |
| 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
|
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 |
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| Contact: Thomas W Ferkol, MD | 314-454-2694 | ferkol_t@wustl.edu |
| Contact: Mary G Boyle, RN | 314-454-4609 | boyle@kids.wustl.edu |
| 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 | |
| Principal Investigator: | Thomas Ferkol, MD | Washington University in St Louis |
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 September 26, 2012
