N/A
N=20
Imaging Airway Liquid Absorption in Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01486199 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Absorptive Clearance Rate — 34.0; 17.7 percent cleared / 80 minutes — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Absorptive clearance scan (Other)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absorptive Clearance Rate |
28.6 | 0.24 |
| PRIMARY Mucociliary Clearance Rate |
22.0 | 0.87 |
| SECONDARY Absorptive Clearance Rate |
28.6 | 0.24 |
| SECONDARY Mucociliary Clearance Rate |
22.0 | 0.87 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Adult healthy control arm:
- subjects 18 years old or older without a diagnosis of lung disease.
- Pediatric CF arm:
- subjects 6-14 years with a diagnosis of cystic fibrosis as determined by sweat test or genotype
- subjects who are clinically stable as determined by the pediatrician co-investigator
- subjects must have a previously demonstrated ability to perform reproducible pulmonary function testing based on previous clinical visits.
- 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:
- FEV1%p < 80% of predicted
- nursing mother
- positive urine pregnancy test or unwilling to test
- cigarette smoker (regular smoking within 6 months of study).
- Pediatric CF arm:
- FEV1%p < 40% of predicted
- nursing mother
- positive urine pregnancy test for females of childbearing potential
- unable or unwilling to comply with test procedure
- cigarette smoker (regular smoking within 6 months of study).
- Subjects unable to lie recumbent without moving for the 80 minute imaging period will be excluded.
Data sourced from ClinicalTrials.gov (NCT01486199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.