Compare Technegas Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging for Pulmonary Embolism

Pulmonary Embolism Clinical Trial

Official title: A Comparison of Technegas® Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging in Subjects Being Evaluated for Pulmonary Embolism

Status Terminated

Clinical Trial Summary

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).

Clinical Trial Description

This is a Phase 3 within-subject trial of Technegas Ventilation SPECT and Tc-99m MAA perfusion imaging compared to xenon (Xe-133) Ventilation Planar and Tc-99m MAA perfusion imaging for the diagnosis of PE. Diagnosis of PE provided by review of the subjects' documented clinical information after 30 days of follow-up. Primary assessments of efficacy will be based on an independent blind reads of the Technegas V/Q SPECT images by three different readers and the independent blind reads of Xe 133 V/Q planar images by three different readers. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

• NCT number: NCT01458639
• Study type: Interventional
• Source: Cyclomedica Australia PTY Limited
• Status: Terminated
• Phase: Phase 3
• Start date: August 2012
• Completion date: June 2015