Imaging Airway Liquid Absorption in Cystic Fibrosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01486199
First received: November 18, 2011
Last updated: June 19, 2013
Last verified: June 2013

November 18, 2011
June 19, 2013
October 2011
October 2014   (final data collection date for primary outcome measure)
Longitudinal change in absorptive clearance [ Time Frame: t=2 years ] [ Designated as safety issue: No ]
The absorption rate of the small molecule radiopharmaceutical In111-DTPA from the airways will be compared at baseline and at t=2years. This will allow us to determine how absorptive clearance changes with disease development.
  • Longitudinal change in absorptive clearance [ Time Frame: t=0 and 2 years ] [ Designated as safety issue: No ]
    The absorption rate of the small molecule radiopharmaceutical In111-DTPA from the airways will be compared at baseline and at t=2years. This will allow us to determine how absorptive clearance changes with disease development.
  • Change in absorptive clearance in response to a therapy [ Time Frame: t=0 and 30 days ] [ Designated as safety issue: No ]
    The absorption rate of the small molecule radiopharmaceutical In111-DTPA from the airways will be compared at baseline and after the inhalation of 7% hypertonic saline (performed on day 30.)
  • Short-term change in absorptive clearance (repeatability) [ Time Frame: t=0 and 30 days ] [ Designated as safety issue: No ]
    The absorption rate of the small molecule radiopharmaceutical In111-DTPA from the airways will be compared at baseline and at day 30. This will determine the intra-subject repeatability of the technique.
Complete list of historical versions of study NCT01486199 on ClinicalTrials.gov Archive Site
Mucociliary clearance rate [ Time Frame: t=0 ] [ Designated as safety issue: No ]
The clearance rate of radiolabeled particles from the lung (Technetium 99m-sulfur colloid)
Same as current
Not Provided
Not Provided
 
Imaging Airway Liquid Absorption in Cystic Fibrosis
Imaging Airway Liquid Absorption in Cystic Fibrosis

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-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 diethylene triamine pentaacetic acid; In-DTPA) and the other a non-absorbable particle (Technetium 99m labeled sulfur colloid; Tc-SC). The overarching hypothesis is that 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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Cystic Fibrosis
Other: Absorptive clearance scan
Subjects will inhale a nebulized mixture of the radiopharmaceuticals Indium 111-DTPA and Technetium 99m-sulfur colloid.
  • Experimental: CF pediatric
    In the pediatric arm 10 CF subjects ages 6-14 will perform absorptive clearance scans at baseline and at t=2 years.
    Intervention: Other: Absorptive clearance scan
  • Experimental: Controls adult
    In the adult control arm 10 healthy adult subjects will perform a single absorptive clearance scan.
    Intervention: Other: Absorptive clearance scan
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
October 2014
October 2014   (final data collection date for primary outcome measure)

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.
Both
6 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01486199
1 R01 HL108929-01, R01HL108929
Yes
University of Pittsburgh
University of Pittsburgh
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Tim Corcoran, Ph.D. University of Pittsburgh
University of Pittsburgh
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP