FDG-PET Imaging in Young Cystic Fibrosis Patients
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 16, 2009
CompletedFirst Posted
Study publicly available on registry
February 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
July 24, 2018
CompletedJuly 24, 2018
June 1, 2018
3 years
February 16, 2009
May 12, 2017
June 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Sputum Neutrophil Elastase (NE) Concentration
Sample collected within 2-hours of PET scan
Study Arms (2)
Stable lung function
OTHER\* 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.
Rapidly deteriorating lung function
OTHER\* 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas Ferkol, MD
- Organization
- Washington University
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Ferkol, MD
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
February 16, 2009
First Posted
February 18, 2009
Study Start
February 1, 2009
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
July 24, 2018
Results First Posted
July 24, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- 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.
- 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.
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.