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Imaging Airway Liquid Absorption in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Absorptive clearance scan
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cystic Fibrosis focused on measuring cystic fibrosis, mucociliary clearance, airway surface liquid, nuclear medicine

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CF pediatric

Controls adult

Arm Description

In the pediatric arm 10 CF subjects ages 6-14 will perform absorptive clearance scans at baseline and at t=2 years.

In the adult control arm 10 healthy adult subjects will perform a single absorptive clearance scan.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 18, 2011
Last Updated
July 24, 2017
Sponsor
University of Pittsburgh
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01486199
Brief Title
Imaging Airway Liquid Absorption in Cystic Fibrosis
Official Title
Imaging Airway Liquid Absorption in Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis, mucociliary clearance, airway surface liquid, nuclear medicine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CF pediatric
Arm Type
Experimental
Arm Description
In the pediatric arm 10 CF subjects ages 6-14 will perform absorptive clearance scans at baseline and at t=2 years.
Arm Title
Controls adult
Arm Type
Experimental
Arm Description
In the adult control arm 10 healthy adult subjects will perform a single absorptive clearance scan.
Intervention Type
Other
Intervention Name(s)
Absorptive clearance scan
Intervention Description
Subjects will inhale a nebulized mixture of the radiopharmaceuticals Indium 111-DTPA and Technetium 99m-sulfur colloid.
Primary Outcome Measure Information:
Title
Absorptive Clearance Rate
Description
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
Title
Mucociliary Clearance Rate
Description
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
Secondary Outcome Measure Information:
Title
Absorptive Clearance Rate
Description
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
Title
Mucociliary Clearance Rate
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Corcoran, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27009167
Citation
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.
Results Reference
derived
PubMed Identifier
24743971
Citation
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.
Results Reference
derived
Links:
URL
https://www.dom.pitt.edu/paccm/faculty_info.aspx/Corcoran5127
Description
Dr. Corcoran's University Webpage

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Imaging Airway Liquid Absorption in Cystic Fibrosis

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