Imaging Airway Liquid Absorption in Cystic Fibrosis

NCT01486199 | Completed Results DMC

• 2 other identifiers: 1R01HL108929-01R01HL108929
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; mucociliary clearance; airway surface liquid; nuclear medicine

Outcome Measures

Primary Outcomes (2)

• 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.

  study day 1

• 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.

  study day 1

Secondary Outcomes (2)

• Absorptive Clearance Rate

  t=2 years

• Mucociliary Clearance Rate

  t=2 years, measure made 80 minutes after radiopharmaceutical inhalation

Study Arms (2)

CF pediatric

EXPERIMENTAL

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

Controls adult

EXPERIMENTAL

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

Other: Absorptive clearance scan

Interventions

Absorptive clearance scan OTHER

Subjects will inhale a nebulized mixture of the radiopharmaceuticals Indium 111-DTPA and Technetium 99m-sulfur colloid.

CF pediatric; Controls adult

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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.

  PMID: 27009167 DERIVED

• 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.

  PMID: 24743971 DERIVED

Related Links

• Dr. Corcoran's University Webpage

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: Tim Corcoran
• Organization: University of Pittsburgh

corcorante@upmc.edu

412-624-8918

Study Officials

• Tim Corcoran, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 18, 2011
• First Posted: December 6, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 25, 2017
• Results First Posted: September 25, 2017

Record last verified: 2017-07

Locations

US (1)