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Imaging Airway Liquid Absorption in Cystic Fibrosis

This study is currently recruiting participants.
Verified June 2012 by University of Pittsburgh
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01486199
First received: November 18, 2011
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

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 adult and pediatric CF patients and healthy control subjects.


Condition Intervention
Cystic Fibrosis
 Drug: Inhaled hypertonic saline (7%)
Other: Absorptive clearance scan

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Imaging Airway Liquid Absorption in Cystic Fibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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.

  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 52
Study Start Date: October 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CF adult response
In the response arm 16 CF adult subjects will perform absorptive clearance scans at baseline, t=30 days, and t=2 years. During the second scan they will inhale 7% hypertonic saline in order to test the response of absorptive clearance to the therapy.
 Drug: Inhaled hypertonic saline (7%)
single administration
Other: Absorptive clearance scan
Subjects will inhale a nebulized mixture of the radiopharmaceuticals Indium 111-DTPA and Technetium 99m-sulfur colloid.
Experimental: CF adult repeatability
In the repeatability arm 16 CF adult subjects will perform absorptive clearance scans at baseline, t=30 days, and t=2 years. Scanning techniques performed at t=0 and t=30 days will be identical and the results will be compared to establish the repeatability of the technique.
 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.
 Other: Absorptive clearance scan
Subjects will inhale a nebulized mixture of the radiopharmaceuticals Indium 111-DTPA and Technetium 99m-sulfur colloid.
Experimental: Controls adult
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult CF arms:

    • subjects 18 years old or older with a diagnosis of cystic fibrosis as determined by sweat test or genotype
    • subjects who are clinically stable as determined by a physician co-investigator.

  • 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 CF arm:

    • intolerant to hypertonic saline
    • FEV1%p < 40% of predicted
    • nursing mother
    • positive urine pregnancy test or unwilling to test
    • unwilling to stop hypertonic saline therapy for 72 hours prior to each test day
    • cigarette smoker (regular smoking within 6 months of study).

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486199

Contacts
Contact: Adrienne DeRicco, RN 1-877-296-9026 Adrienne.Horn@chp.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Adrienne DeRicco, R.N.     877-296-9026     Adrienne.Horn@chp.edu    
Principal Investigator: Tim Corcoran, Ph.D.            
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Tim Corcoran, Ph.D. University of Pittsburgh
  More Information

Additional Information:
Dr. Corcoran's University Webpage  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01486199     History of Changes
Other Study ID Numbers: 1 R01 HL108929-01, R01HL108929
Study First Received: November 18, 2011
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pittsburgh:
cystic fibrosis
mucociliary clearance
airway surface liquid
nuclear medicine

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013