Clinical trial NCT03054870: A Comparison of Technegas and Xenon-133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy
Official title: A Comparison of Technegas® and Xenon 133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lung Structure Determination
Keywords: pulmonary ventilation
ventilation scintigraphy
Lead sponsor: Cyclomedica Australia PTY Limited
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: CROSSOVER
Intervention model description: Subjects will undergo standard of care Xe-133 ventilation scintigraphy per medical needs followed by investigational Technegas ventilation scintigraphy per protocol.
Primary purpose: OTHER

Brief 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.

Detailed 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 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.

Primary outcomes:
measure: Blinded Readers Percent Agreement (PA) for Matching Image Views
timeFrame: The median duration of Technegas imaging was 22 minutes. Blinded reader assessments of images ranged from <1 month to 16 months following the imaging (median 5 months).
Secondary outcomes:
measure: Blinded Readers Percent Agreement (PA) for All Image Views
timeFrame: The median duration of Technegas imaging was 22 minutes. Blinded reader assessments of images ranged from <1 month to 16 months following the imaging (median 5 months).
measure: Percent Agreement Measuring Inter-observer Agreement
timeFrame: The median duration of Technegas imaging was 22 minutes. Blinded reader assessments of images ranged from <1 month to 16 months following the imaging (median 5 months).
measure: Kappa Statistics Between Pairs of Blinded Readers by Lung Region
timeFrame: The median duration of Technegas imaging was 22 minutes. Blinded reader assessments of images ranged from <1 month to 16 months following the imaging (median 5 months).
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic in Jacksonville, FL
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Saint Louis
country: United States
facility: Washington University Medical Center, Barnes-Jewish Hospital - Center for Advanced Medicine
state: Missouri
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Temple
country: United States
facility: Scott & White Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Science Center
state: Utah
Study officials:
affiliation: Certus International, Inc.
name: Edward M Aten, MD
role: STUDY_DIRECTOR
References: