Status and phase
Conditions
Treatments
About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subjects will be enrolled in Cohort 1 if they meet the following requirements:
Subjects will be enrolled in Cohort 2 if they meet the above criteria AND subject is likely to have pulmonary embolism based on one or more of the following:
Exclusion criteria
Subject
Primary purpose
Allocation
Interventional model
Masking
18 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal