Repeatability and Response Study of Absorptive Clearance Scans

November 2, 2018 updated by: Tim Corcoran
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cystic Fibrosis (CF) is an autosomal recessive genetic disease, caused by mutations of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) that impairs ion transport at epithelial surfaces. This results in the accumulation of dehydrated secretions in the airways and chronic infection and inflammation in the lungs, leading to significant morbidity and mortality. The investigators understanding of CF pathogenesis has increased substantially and many new targeted therapies are being developed to treat this disease, however, the measurements of clinical efficacy used to evaluate these therapies require long trials to demonstrate an effect. New translational techniques are needed to assess changes in the most basic aspects of the disease and allow for the rapid screening of disease-altering therapies. The investigators have recently developed a novel aerosol-based imaging technique to measure liquid absorption in the airways - a central pathophysiological process related to CFTR dysfunction. The investigators propose that airway liquid hyper-absorption is a key link between cellular defects in ion and fluid transport and progressive airway dysfunction in CF. Thus The investigators technique may provide a measure of disease severity and rapid indication of therapeutic correction in advance of currently available outcome measures.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Repeatability
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
Subjects inhale a nebulized mixture of the radiopharmaceuticals Indium 111-DTPA and Technetium 99m sulfur colloid.
Experimental: Response
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
Subjects inhale a nebulized mixture of the radiopharmaceuticals Indium 111-DTPA and Technetium 99m sulfur colloid.
Drug: inhaled hypertonic saline (7%)
nebulized hypertonic saline (7%)
Other Names:
  • Hypersal
Drug: mannitol inhalation powder
mannitol inhalation powder
Other Names:
  • Bronchitol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
absorptive clearance variability
Time Frame: 30 days
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
Time Frame: 14 day
The change in absorptive clearance demonstrated in response to therapy when compared to baseline
14 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tim Corcoran

Investigators

  • Principal Investigator: Tim Corcoran, Ph.D., University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (Estimate)

June 26, 2013

Study Record Updates

Last Update Posted (Actual)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 2, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1RO1 HL108929-01 (B)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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