Ignite Creation Date:
2024-05-05 @ 11:56 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01458639
Status:
TERMINATED
Last Update Posted:
2015-11-10
First Post:
2011-10-19
Brief Title:
Compare Technegas Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging for Pulmonary Embolism
Sponsor:
Cyclomedica Australia PTY Limited
Organization:
Cyclomedica Australia PTY Limited
Study Overview
Official Title:
A Comparison of Technegas Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging in Subjects Being Evaluated for Pulmonary Embolism
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Decision to change trial design
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase 3 within-subject trial of Technegas VQ SPECT and Tc-99m macro-aggregated albumin MAA imaging compared to Xenon-133 VQ planar and Tc-99m macroaggregate of albumin MAA imaging for the diagnosis of Pulmonary Embolism PE
Detailed 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 VQ SPECT images by three different readers and the independent blind reads of Xe 133 VQ planar images by three different readers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None