A Comparison of Technegas and Xenon-133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.