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Sponsors and Collaborators: |
University of Pittsburgh Cystic Fibrosis Foundation |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00248755 |
The objective of this study is to determine the effect of airway surface liquid (ASL) volume on mucociliary clearance in cystic fibrosis (CF). A two-isotope nuclear medicine technique will be utilized. This pilot trial will include the imaging of n=7 CF subjects and n=7 healthy subjects. The trial will include one study visit per subject that will take approximately 3 hours. Hypothesis: The simultaneous imaging of both a "floating" and a "penetrating" radioisotope tag will allow the relative effect of airway surface liquid volume on mucociliary clearance to be determined when evaluated in CF and normal subjects.
Condition | Intervention |
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Cystic Fibrosis |
Procedure: mucociliary clearance scan |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Pilot Study of a New Technique for Assessing Mucociliary Clearance and Airway Surface Liquid Volume in Cystic Fibrosis |
Estimated Enrollment: | 14 |
Study Start Date: | November 2005 |
Study Completion Date: | August 2006 |
Improper function of the mucociliary clearance system in the Cystic Fibrosis (CF) lung is a major factor contributing to the chronic respiratory manifestations of the disease. Normally this host defense mechanism removes inhaled pathogens and toxins from the inner surfaces of the lung. In CF, mutations in the CF gene result in dysfunction of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) ion channel on the cells that line the airway epithelium, causing improper fluxes of ions such as sodium, chloride, and bicarbonate. The so called "low volume" hypothesis of CF pathogenesis contends that the liquid lining the airways becomes very thin and viscous due to abnormal absorption of sodium from the airways, which draws water out of the airways, partially or totally defeating mucociliary clearance. The rate at which the mucociliary system clears materials from the lungs can be quantified using a nuclear medicine test called a mucociliary clearance scan. This study pilots a new variation of the mucociliary clearance scan that uses both "floating" and "penetrating" radioisotope tags. The difference in clearance between these tags will provide information on how airway surface liquid volume affects mucociliary clearance. This pilot trial will include the imaging of n=5 CF subjects and n=5 healthy subjects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Timothy E Corcoran, Ph.D. | University of Pittsburgh |
Study ID Numbers: | CFFR883 |
Study First Received: | November 2, 2005 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00248755 |
Health Authority: | United States: Food and Drug Administration |
cystic fibrosis mucociliary clearance nuclear medicine |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis |
Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
Pathologic Processes |