Repeatability and Response Study of Absorptive Clearance Scans

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tim Corcoran; University of Pittsburgh
• Treatments: Mannitol

Criteria

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)