drugset / Trial / NCT03054870

A Comparison of Technegas and Xenon-133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy

NCT03054870 ↗

Phase 3 Terminated 226 enrolled Cyclomedica Australia PTY Limited
NaCrossoverOpen-labelOther

Summary

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.

Timeline

Start
2017-09-01
Primary completion
2020-09-18
Completion
2020-11-23

Outcome

Met primary endpoint

Stopped: “Trial met primary efficacy endpoint target. No additional subjects necessary.”

registry NUMBER Blinded Reader 03: 76.2 (72.3 to 79.6) percentage of lung regions NCT03054870 ↗

registry NUMBER Blinded Reader 04: 70.7 (66.4 to 74.7) percentage of lung regions NCT03054870 ↗

registry NUMBER Blinded Reader 05: 80.1 (76.4 to 83.3) percentage of lung regions NCT03054870 ↗

registry analysis (non-inferiority test); Blinded Reader 03 vs Blinded Reader 04 vs Blinded Reader 05; p <0.0141 NCT03054870 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Technegas Diagnostic / imaging agent 40.7 mbq Inhaled
Subject Xenon-133 Diagnostic / imaging agent 370 mbq Inhaled
Subject Xenon-133 Diagnostic / imaging agent 1110 mbq Inhaled

Indications

No indication recorded.