Repeatability and Response Study of Absorptive Clearance Scans

NCT01887197 | Completed Phase 1 DMC

• 2 other identifiers: 1RO1 HL108929-01 (B)1R01HL108929-01
• Study Type: interventional
• Target: 24
• 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 diethylene triamine pentaacetic 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 determine whether the imaging technique will demonstrate similar results when it is repeated on different days. They will also determine how their results change when subjects utilize several common CF medications.

Conditions

Cystic Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• absorptive clearance variability

  The difference in absorptive clearance measured on two different study days in the same subjects as an indicator of measurement variability

  30 days

• absorptive clearance response

  The change in absorptive clearance demonstrated in response to therapy when compared to baseline

  14 day

Study Arms (2)

Repeatability

EXPERIMENTAL

Subjects perform two sequential absorptive clearance scans (within 30 days) to determine the repeatability of the technique. Subjects also perform a third scan two years later so that longitudinal change can be measured.

Other: Absorptive clearance scan

Response

EXPERIMENTAL

Subjects perform three different absorptive clearance scans. One is a baseline measurement while the other two measure absorptive clearance after an intervention (inhaled hypertonic saline, mannitol inhalation powder).

Other: Absorptive clearance scan; Drug: inhaled hypertonic saline (7%); Drug: mannitol inhalation powder

Interventions

Absorptive clearance scan OTHER

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

Repeatability; Response

inhaled hypertonic saline (7%) DRUG

nebulized hypertonic saline (7%)

Also known as: Hypersal

Response

mannitol inhalation powder DRUG

mannitol inhalation powder

Also known as: Bronchitol

Response

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• one second forced expiratory volume (FEV1) \<50% of predicted
• nursing mother
• positive urine pregnancy test or unwilling to test
• cigarette smoker
• unwilling to stop hypertonic saline therapy for 72 hours prior to each test day
• are intolerant to hypertonic saline (response only)
• are intolerant to any inhaled therapies (response only)
• fail mannitol tolerance testing (response only)
• have a history of excessive (uncontrollable) coughing after an osmotic stimulus (response only)
• have a history of hemoptysis (response only)

Sponsors & Collaborators

• Tim Corcoran: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• Corcoran TE, Thomas KM, Brown S, Myerburg MM, Locke LW, Pilewski JM. Liquid hyper-absorption as a cause of increased DTPA clearance in the cystic fibrosis airway. EJNMMI Res. 2013 Feb 27;3(1):14. doi: 10.1186/2191-219X-3-14.

  PMID: 23446051 BACKGROUND

• Corcoran TE, Thomas KM, Myerburg MM, Muthukrishnan A, Weber L, Frizzell R, Pilewski JM. Absorptive clearance of DTPA as an aerosol-based biomarker in the cystic fibrosis airway. Eur Respir J. 2010 Apr;35(4):781-6. doi: 10.1183/09031936.00059009. Epub 2009 Aug 28.

  PMID: 19717485 BACKGROUND

• 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

Related Links

• Dr. Corcoran's Research Page

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Mannitol

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

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Tim Corcoran, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-06

Locations

US (1)