Imaging Airway Liquid Absorption in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Imaging Airway Liquid Absorption in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486199
• Other study ID #: 1R01HL108929-01
• Secondary ID: R01HL108929
• Status: Completed
• Phase: N/A
• First received: November 18, 2011
• Last updated: July 24, 2017
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: July 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators have recently developed a novel aerosol-based imaging technique to detect changes in liquid absorption in the airways - a central pathophysiological process known to be important in cystic fibrosis (CF) lung disease. This technique may provide a measure of disease severity and indication of therapeutic correction in advance of currently available outcome measures. It involves the simultaneous delivery of two radiopharmaceuticals by inhalation: one an absorbable small-molecule (Indium-111 labeled diethylenetriaminepentaacetic acid; In-DTPA) and the other a non-absorbable particle (Technetium 99m labeled sulfur colloid; Tc-SC). The overarching hypothesis is that In-DTPA absorption provides a quantifiable, non-invasive measurement of airway liquid absorption that (a) is sensitive to CF genotype, (b) uniquely identifies basic disease phenotype and predicts disease severity, and (c) is modulated by therapeutic interventions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Absorptive clearance scan
Subjects will inhale a nebulized mixture of the radiopharmaceuticals Indium 111-DTPA and Technetium 99m-sulfur colloid.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Absorptive Clearance Rate	Absorptive Clearance Rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of In-DTPA from the lungs.	t=2 years
Secondary	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.	t=2 years, measure made 80 minutes after radiopharmaceutical inhalation

External Links

•   Dr. Corcoran's University Webpage