A Comparison of Technegas and Xenon-133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy
Stopped early · Phase 3
Conditions studied: Lung Structure Determination
In brief
Phase 3 within-subject non-inferiority trial of Technegas ventilation imaging compared to Xenon-133 (Xe-133) ventilation imaging to demonstrate the non-inferiority of Technegas compared to Xe-133 ventilation studies with respect to subject pulmonary ventilatory distribution. Subjects will undergo site-specific standard of care (SOC) Xe-133 imaging per medical needs followed by Technegas ventilation imaging per study protocol.
Key facts
- Study ID
- NCT03054870
- Run by
- Cyclomedica Australia PTY Limited
- People needed
- 226
- Starts
- 2017-09-01
- Expected to finish
- 2020-11-23
- Last updated by the study team
- 2021-09-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female subject at least 18 years of age.
- Subject is a candidate for ventilation imaging.
- Subject must be willing and able to provide informed consent.
- Subject must be stable and able to undergo Xe-133 planar imaging and Technegas planar imaging.
- Subject must be willing and agree to complete study procedures.
- Subject is using adequate birth control, if female and fertile. Adequate birth control is defined as surgical sterilization, hormone contraceptive use or intrauterine device (IUD).
- Female subject of child-bearing potential has a negative urine or serum pregnancy test.
- Subject has had or is scheduled to have a chest X-ray within 24 hours prior to the investigational imaging study.
You may not qualify if…
- Subject has been administered any other radiopharmaceutical within a timeframe that might cause interference with study imaging.
- Subject is a pregnant or lactating female.
- Subject has received Technegas in the past.
- Subject has received an investigational drug within 30 days prior to dosing.
- Subject is hemodynamically unstable.
Where it is running
- Morton Plant Hospital — Clearwater, Florida, United States
- Mayo Clinic in Jacksonville, FL — Jacksonville, Florida, United States
- Loyola University Medical Center — Maywood, Illinois, United States
- Washington University Medical Center, Barnes-Jewish Hospital - Center for Advanced Medicine — St Louis, Missouri, United States
- Duke University Hospital — Durham, North Carolina, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- Houston Methodist Hospital — Houston, Texas, United States
- Scott & White Medical Center — Temple, Texas, United States
- University of Utah Health Science Center — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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