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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDG-PET | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Sample collected within 2-hours of PET scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Ferkol, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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.
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.
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.
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January 2009-December 2012, St. Louis Children's Hospital Cystic Fibrosis Clinics (St. Louis)
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| ID | Title | Description |
|---|---|---|
| FG000 | Stable Lung Function | Group S 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. |
| FG001 | Rapidly Decline Lung Function | Group R 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stable Lung Function | 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. |
| BG001 | Rapidly Declining Lung Function |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | CF adolescents and young adults, ages 12 to 21 years, who did not have CFRD. | Posted | Mean | Standard Deviation | mL/min/mL | At the time of FDG scan, 1 to 2 hours |
|
At the time of and immediately following FDG-PET scan, an average of 2-hours
No difference
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stable Lung Function | No adverse events | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Ferkol, MD | Washington University | 314 454 6000 |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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.
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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, as defined in our previous study.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Group R (n = 8) will contain CF patients, aged 12-21 years old, with rapidly deteriorating lung function during the past 4 years |
|
|
| Secondary | 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 | Not every participant in the stable lung function group could produce sputum. | Posted | Mean | Standard Deviation | microgram (mcg) NE /mcg protein | Sample collected within 2-hours of PET scan |
|
|
|
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Rapidly Declining Lung Function | No adverse events | 0 | 8 | 0 | 8 | 0 | 8 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |