A Comparison of Technegas and Xenon-133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy

Study ID
STU 072017-077

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Clements University Hospital

Contact
Jamie Pacicco
214 648 5982
Jamie.Pacicco@UTSouthwestern.edu

Principal Investigator
Orhan Oz, M.D., Ph.D.

Official Title

A Comparison of Technegas® and Xenon 133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy

Brief Overview

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.

Description

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.

Eligibility

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, including returning for all 24-hour follow-up safety assessments, such as physical examination and clinical laboratory evaluation.
- 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.