{"entity":{"id":"nct03054870","kind":"trial","name":"CYC-009: Technegas versus xenon-133 ventilation imaging","aka":[],"tldr":"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.","summary":"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.","status":"historic","asOf":"2026-09-23","links":[{"label":"ClinicalTrials.gov NCT03054870","url":"https://clinicaltrials.gov/study/NCT03054870"},{"label":"CYC-009 protocol and statistical analysis plan (ClinicalTrials.gov document)","url":"https://cdn.clinicaltrials.gov/large-docs/70/NCT03054870/Prot_SAP_001.pdf"}],"tags":["ventilation","registration trial"],"related":["technegas","cyclopharm","pulmonary-embolism-vq"],"indications":[],"sections":[],"technologies":[],"targets":[],"drugs":["technegas"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03054870","phase":"3","setting":"Adults referred for ventilation scintigraphy, imaged with both Technegas and xenon-133 by planar technique, to test whether Technegas is non-inferior to xenon-133 for the distribution of pulmonary ventilation. This is the registration study behind the 2023 US approval; ClinicalTrials.gov records its status as terminated with 226 participants actually enrolled.","sponsor":"Cyclomedica Australia","enrolled":226,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct03054870/","neighbours":{"drug":[{"id":"technegas","kind":"drug","name":"Technegas (technetium Tc-99m labelled carbon inhalation aerosol)","route":"/drugs/technegas/"}],"company":[{"id":"cyclopharm","kind":"company","name":"Cyclopharm","route":"/companies/cyclopharm/"}],"indication":[{"id":"pulmonary-embolism-vq","kind":"indication","name":"Pulmonary embolism: ventilation/perfusion imaging","route":"/indications/pulmonary-embolism-vq/"}]}}