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A Comparison of Technegas® Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging in Subjects Being Evaluated for Pulmonary Embolism
Phase 3 within-subject trial of Technegas V/Q SPECT and Tc-99m macro-aggregated albumin (MAA) imaging compared to Xenon-133 V/Q planar and Tc-99m macroaggregate of albumin (MAA) imaging for the diagnosis of Pulmonary Embolism (PE).
Details
| Lead sponsor | Cyclomedica Australia PTY Limited |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Enrolment | 18 |
| Start date | 2012-08 |
| Completion | 2015-06 |
Conditions
- Pulmonary Embolism
Interventions
- Technegas V SPECT imaging
- Xenon-133 Ventilation Planar imaging
Primary outcomes
- Sensitivity of Technegas V/Q SPECT for the Diagnosis of PE — Prospective, 30 days follow-up
Compared to the sensitivity of Xenon V/Q Planar imaging. "Truth" based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up. - Specificity of Technegas V/Q SPECT for the Diagnosis of PE. — Prospective, 30 days follow-up
Compared to the specificity of Xenon V/Q Planar imaging. "Truth" based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up.
Countries
United States