NCT01486199

Imaging Airway Liquid Absorption in Cystic Fibrosis

Completed NA Results posted Last updated 24 July 2017

What this trial tests

NA trial testing Absorptive clearance scan in Cystic Fibrosis in 20 participants. Completed in 1 October 2014.

Timeline

1 October 2011

Primary endpoint
1 October 2014

1 October 2014

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	20
Start date	1 October 2011
Primary completion	1 October 2014
Estimated completion	1 October 2014
Sites	1 location across United States

Drugs / interventions tested

• Absorptive clearance scan

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

University of Pittsburgh

Who can join

6 and older, any sex, with Cystic Fibrosis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Absorptive Clearance Rate
  Time frame: study day 1
  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
  Time frame: study day 1
  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.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
   Locke LW, Myerburg MM, Weiner DJ, Markovetz MR, et al · · 2016 · cited 22× · PMID 27009167 · DOI 10.1183/13993003.01880-2015
2. Quantitative imaging of airway liquid absorption in cystic fibrosis.
   Locke LW, Myerburg MM, Markovetz MR, Parker RS, et al · · 2014 · cited 17× · PMID 24743971 · DOI 10.1183/09031936.00220513
3. A physiologically-motivated compartment-based model of the effect of inhaled hypertonic saline on mucociliary clearance and liquid transport in cystic fibrosis.
   Markovetz MR, Corcoran TE, Locke LW, Myerburg MM, et al · · 2014 · cited 8× · PMID 25383714 · DOI 10.1371/journal.pone.0111972
4. Multiprobe Nuclear Imaging of the Cystic Fibrosis Lung as a Biomarker of Therapeutic Effect.
   Corcoran TE, Huber AS, Myerburg MM, Weiner DJ, et al · · 2019 · cited 4× · PMID 30969149 · DOI 10.1089/jamp.2018.1491