Back to resultsFDG-PET Imaging in Young Cystic Fibrosis Patients
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FDG-PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Cystic Fibrosis
Eligibility 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, 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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Stable lung function
Rapidly deteriorating lung function
Arm 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.
* 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00846053
First Posted
February 16, 2009
Last Updated
June 27, 2018
Sponsor
Washington University School of Medicine
Collaborators
Cystic Fibrosis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00846053
Brief Title
FDG-PET Imaging in Young Cystic Fibrosis Patients
Official Title
FDG-PET Imaging in Young Cystic Fibrosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2009 (Actual)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Cystic Fibrosis Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
In this pilot study, we examined the value of FDG-PET scans as a noninvasive measure of neutrophilic inflammation in adolescents and young adults with cystic fibrosis. All subjects underwent scans.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stable lung function
Arm Type
Other
Arm 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.
Arm Title
Rapidly deteriorating lung function
Arm Type
Other
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
FDG-PET
Intervention Description
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.
Primary Outcome Measure Information:
Title
Kinetic Influx Constant (Ki)
Description
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.
Time Frame
At the time of FDG scan, 1 to 2 hours
Secondary Outcome Measure Information:
Title
Sputum Neutrophil Elastase (NE) Concentration
Description
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
Time Frame
Sample collected within 2-hours of PET scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Ferkol, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data generated will be published at the end of the project, consistent with normal scientific practices. Such research data will be anonymized to prevent the disclosure of personal identifiers. In return for the use of data, investigators will acknowledge our grant number in publications and presentations, and in productivity reports on publications or funding that were derived from the project, and they will not distribute materials to third-parties without notification. There will be no charge for sharing data unless the request requires effort beyond what can be subsumed under normal project budgeted effort. If the request justifies a charge, the cost is kept to a minimum and based on actual expenses.
IPD Sharing Time Frame
Research data will be made available after the main findings from the final research data set have been accepted for publication. The data will be available indefinitely thereafter.
IPD Sharing Access Criteria
Data may be shared with collaborators as approved by the Principal Investigator based on the following criteria: scientific merit, feasibility and IRB issues, appropriateness of principal investigator qualifications, and appropriateness to the project's overall goals and themes. Approval of the relevant co-investigators will be also sought and reviewed by the principal investigators.
Learn more about this trial
FDG-PET Imaging in Young Cystic Fibrosis Patients
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