An interventional study of Absorptive clearance scan in Cystic Fibrosis, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 6 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-25.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Basic science
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 20 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult healthy control arm:
Pediatric CF arm:
Exclusion Criteria:
Adult healthy control arm:
Pediatric CF arm:
In the pediatric arm 10 CF subjects ages 6-14 will perform absorptive clearance scans at baseline and at t=2 years.
Other: Absorptive clearance scan
In the adult control arm 10 healthy adult subjects will perform a single absorptive clearance scan.
Other: Absorptive clearance scan
Subjects will inhale a nebulized mixture of the radiopharmaceuticals Indium 111-DTPA and Technetium 99m-sulfur colloid.
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.
Time frame: 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.
Time frame: study day 1
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.
Time frame: t=2 years
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.
Time frame: t=2 years, measure made 80 minutes after radiopharmaceutical inhalation
| Milestone | CF Pediatric | Controls Adult |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 9 |
| Not completed | 0 | 1 |
| Milestone | CF Pediatric | Controls Adult |
|---|---|---|
| Started | 10 | 0 |
| Completed | 9 | 0 |
| Not completed | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
| Milestone | CF Pediatric | Controls Adult |
|---|---|---|
| Started | 9 | 0 |
| Completed | 9 | 0 |
| Not completed | 0 | 0 |
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.
| percent cleared / 80 minutes | CF Pediatric | Controls Adult |
|---|---|---|
| Absorptive Clearance Rate | 34.0 ± 10.4 | 17.7 ± 6.9 |
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.
| percent cleared / 80 minutes | CF Pediatric | Controls Adult |
|---|---|---|
| Mucociliary Clearance Rate | 22.8 ± 13.7 | 31.4 ± 13.1 |
Absorptive Clearance Rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of In-DTPA from the lungs.
| percent cleared / 80 min | CF Pediatric | Controls Adult |
|---|---|---|
| Absorptive Clearance Rate | 28.6 ± 9.9 | — |
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.
| percent cleared / 80 minutes | CF Pediatric | Controls Adult |
|---|---|---|
| Mucociliary Clearance Rate | 22.0 ± 13.1 | — |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CF Pediatric | — | 0/10 (0%) | 0/10 (0%) |
| Controls Adult | — | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | CF Pediatric | Controls Adult | Total |
|---|---|---|---|
| Mean | 10.5 ± 1.5 | 31.2 ± 15.0 | 20.9 ± 14.9 |
| Sex: Female, Male(Participants) | CF Pediatric | Controls Adult | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 5 | 6 | 11 |
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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