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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL108929 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The investigators are developing a new nuclear medicine imaging technique for measuring liquid absorption in the airways that can be applied to screen new medications being developed to treat cystic fibrosis (CF). The investigators believe that the absorption of the small molecule radiopharmaceutical Indium 111-diethylenetriaminepentaacetic acid (In-DTPA) will indicate changes in liquid absorption in the airways and demonstrate whether new CF medications will be effective. In this study the investigators will further develop this technique through testing involving pediatric CF patients and healthy control subjects.
The investigators have recently developed a novel aerosol-based imaging technique to detect changes in liquid absorption in the airways - a central pathophysiological process known to be important in cystic fibrosis (CF) lung disease. This technique may provide a measure of disease severity and indication of therapeutic correction in advance of currently available outcome measures. It involves the simultaneous delivery of two radiopharmaceuticals by inhalation: one an absorbable small-molecule (Indium-111 labeled diethylenetriaminepentaacetic acid; In-DTPA) and the other a non-absorbable particle (Technetium 99m labeled sulfur colloid; Tc-SC). The overarching hypothesis is that In-DTPA absorption provides a quantifiable, non-invasive measurement of airway liquid absorption that (a) is sensitive to CF genotype, (b) uniquely identifies basic disease phenotype and predicts disease severity, and (c) is modulated by therapeutic interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CF pediatric | Experimental | In the pediatric arm 10 CF subjects ages 6-14 will perform absorptive clearance scans at baseline and at t=2 years. |
|
| Controls adult | Experimental | In the adult control arm 10 healthy adult subjects will perform a single absorptive clearance scan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Absorptive clearance scan | Other | Subjects will inhale a nebulized mixture of the radiopharmaceuticals Indium 111-DTPA and Technetium 99m-sulfur colloid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absorptive Clearance Rate | Absorptive clearance rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of Indium 111-diethylenetriaminepentaacetic acid (In-DTPA) from the lungs. | study day 1 |
| Mucociliary Clearance Rate | Mucociliary clearance rate measured 80 minutes after radiopharmaceutical inhalation. Mucociliary clearance rate is the rate of clearance of Technetium sulfur colloid (Tc-SC) from the lungs. | study day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Absorptive Clearance Rate | Absorptive Clearance Rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of In-DTPA from the lungs. | t=2 years |
| Mucociliary Clearance Rate |
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Inclusion Criteria:
Adult healthy control arm:
Pediatric CF arm:
Females in all groups who are of child-bearing potential will need to have a negative urine pregnancy test.
Exclusion Criteria:
Adult healthy control arm:
Pediatric CF arm:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Corcoran, Ph.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27009167 | Derived | Locke LW, Myerburg MM, Weiner DJ, Markovetz MR, Parker RS, Muthukrishnan A, Weber L, Czachowski MR, Lacy RT, Pilewski JM, Corcoran TE. Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung. Eur Respir J. 2016 May;47(5):1392-401. doi: 10.1183/13993003.01880-2015. Epub 2016 Mar 23. | |
| 24743971 | Derived | Locke LW, Myerburg MM, Markovetz MR, Parker RS, Weber L, Czachowski MR, Harding TJ, Brown SL, Nero JA, Pilewski JM, Corcoran TE. Quantitative imaging of airway liquid absorption in cystic fibrosis. Eur Respir J. 2014 Sep;44(3):675-84. doi: 10.1183/09031936.00220513. Epub 2014 Apr 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CF Pediatric | Cystic Fibrosis subjects ages 6-14 |
| FG001 | Controls Adult | Adult control subjects 18 or older |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Study Day |
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| Two Year Period Between Study Days |
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| Study Day at t= 2 Years |
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| ID | Title | Description |
|---|---|---|
| BG000 | CF Pediatric | Cystic Fibrosis subjects ages 6-14 |
| BG001 | Controls Adult | Adult control subjects 18 or older |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Absorptive Clearance Rate | Absorptive clearance rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of Indium 111-diethylenetriaminepentaacetic acid (In-DTPA) from the lungs. | One pediatric subject did not deposit sufficient aerosol to be analyzed. One control subject did not perform imaging procedures after signing consent because of a low result on a screening pulmonary function testing. | Posted | Mean | Standard Deviation | percent cleared / 80 minutes | study day 1 |
|
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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 | CF Pediatric | cystic fibrosis subjects ages 6-14 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim Corcoran | University of Pittsburgh | 412-624-8918 | corcorante@upmc.edu |
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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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Mucociliary clearance rate measured 80 minutes after radiopharmaceutical inhalation. Mucociliary clearance rate is the rate of clearance of Technetium sulfur colloid (Tc-SC) from the lungs.
| t=2 years, measure made 80 minutes after radiopharmaceutical inhalation |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Mucociliary Clearance Rate | Mucociliary clearance rate measured 80 minutes after radiopharmaceutical inhalation. Mucociliary clearance rate is the rate of clearance of Technetium sulfur colloid (Tc-SC) from the lungs. | One pediatric subject did not deposit sufficient aerosol to be analyzed. One control subject did not perform imaging procedures after signing consent because of a low result on a screening pulmonary function testing. | Posted | Mean | Standard Deviation | percent cleared / 80 minutes | study day 1 |
|
|
|
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| Secondary | Absorptive Clearance Rate | Absorptive Clearance Rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of In-DTPA from the lungs. | Only pediatric CF subjects performed 2 year follow-up scan. One subject did not perform the second imaging day since day one image quality was poor. Two other subjects had poor imaging data on follow up day and were therefore not included in analysis. | Posted | Mean | Standard Deviation | percent cleared / 80 min | t=2 years |
|
|
|
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| Secondary | Mucociliary Clearance Rate | Mucociliary clearance rate measured 80 minutes after radiopharmaceutical inhalation. Mucociliary clearance rate is the rate of clearance of Technetium sulfur colloid (Tc-SC) from the lungs. | Only pediatric CF subjects performed 2 year follow-up scan. One subject did not perform the second imaging day since day one image quality was poor. Two other subjects had poor imaging data on follow up day and were therefore not included in analysis. | Posted | Mean | Standard Deviation | percent cleared / 80 minutes | t=2 years, measure made 80 minutes after radiopharmaceutical inhalation |
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|
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|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Controls Adult | adult controls 18 or older | 0 | 10 | 0 | 10 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |