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Lead
Cyclomedica Australia PTY Limited
This is a 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. Primary assessments of efficacy will be based on three blinded readers' assessments of the Technegas and Xe-133 ventilation images in independent reading sessions.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subject at least 18 years of age.
Subject is a candidate for ventilation imaging.
Subject must be willing and able to provide informed consent.
Subject must be stable and able to undergo Xe-133 planar imaging and Technegas planar imaging.
Subject must be willing and agree to complete study procedures.
Subject is using adequate birth control, if female and fertile. Adequate birth control is defined as surgical sterilization, hormone contraceptive use or intrauterine device (IUD).
Female subject of child-bearing potential has a negative urine or serum pregnancy test.
Subject has had or is scheduled to have a chest X-ray within 24 hours prior to the investigational imaging study.
You may not be if
Subject has been administered any other radiopharmaceutical within a timeframe that might cause interference with study imaging.
Subject is a pregnant or lactating female.
Subject has received Technegas in the past.
Subject has received an investigational drug within 30 days prior to dosing.
Subject is hemodynamically unstable.
Clareo Health | A Comparison of Technegas and Xenon-133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy
