Overview
A Comparison of Technegas and Xenon-133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy
Status:
Terminated
Terminated
Trial end date:
2020-11-23
2020-11-23
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Cyclomedica Australia PTY LimitedTreatments:
Xenon
Criteria
Inclusion Criteria:- 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.
Exclusion Criteria:
- 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.