CYC-009: Technegas versus xenon-133 ventilation imaging
The trial that got Technegas approved in the United States: it compared the inhaled carbon aerosol against xenon-133 gas, the agent it was meant to replace.
Overview
CYC-009 (NCT03054870) was a phase 3 non-inferiority study run by Cyclomedica Australia under IND 62660, comparing Technegas with xenon-133 planar lung imaging in patients referred for ventilation scintigraphy. Its stated primary objective was to demonstrate non-inferiority of Technegas to xenon-133 with respect to the distribution of pulmonary ventilation. The registry lists the study as terminated with an actual enrolment of 226. Cyclomedica's own history records the trial completing and the New Drug Application being submitted in 2020; the FDA approved NDA 022335 on 29 September 2023.
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