- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03054870
A Comparison of Technegas and Xenon-133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy
August 30, 2021 updated by: Cyclomedica Australia PTY Limited
A Comparison of Technegas® and Xenon 133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
226
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
-
Clearwater, Florida, United States, 33756
- Morton Plant Hospital
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Jacksonville, Florida, United States, 32224
- Mayo Clinic in Jacksonville, FL
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Illinois
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University Medical Center, Barnes-Jewish Hospital - Center for Advanced Medicine
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Hospital
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
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Houston, Texas, United States, 77030
- Houston Methodist Hospital
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Temple, Texas, United States, 76508
- Scott & White Medical Center
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Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah Health Science Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Xe-133 Followed by Technegas
Subjects first inhaled active comparator Xe-133, approximately 10 to 30 millicuries (mCi), and ventilation planar scintigraphy was performed per site standard of care procedures for subject medical need.
On the same day, following completion of Xe-133 imaging, subjects inhaled experimental Technegas (Technetium-99m labeled carbon particles), approximately 1.1 mCi, and ventilation planar scintigraphy was performed.
|
Xe-133 ventilation scintigraphy
Other Names:
Technegas ventilation scintigraphy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blinded Readers Percent Agreement (PA) for Matching Image Views
Time Frame: 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).
|
Three blinded readers independently assessed the Xe-133 and Technegas images in separate reading sessions.
Readers were blinded to all clinical information except a subject's screening chest X-ray.
Xe-133 images were obtained per site-specific standard of care.
Technegas images included a 6-view image set, and the primary endpoint was based on assessment of the subset of views that matched the Xe-133 image views.
At the start of each case-read, a reader visually divided each lung into 3 regions of approximately equal size arranged craniocaudally (apical, mid, and basal), 6 regions in total, and then assessed each lung region for ventilation according to a three-point scale: 0=absent ventilation, 1=decreased ventilation, 2=normal ventilation.
At the unplanned interim stage, PA between the Xe-133 scores and Technegas scores was tested for non-inferiority at one-sided alpha=0.0141,
equivalent to the lower bound of the 97.18% confidence interval exceeding 60%.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blinded Readers Percent Agreement (PA) for All Image Views
Time Frame: 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).
|
Three blinded readers independently assessed the Xe-133 and Technegas images in separate reading sessions.
Readers were blinded to all clinical information except a subject's screening chest X-ray.
Xe-133 images were obtained per site-specific standard of care.
Technegas images included a 6-view image set.
Two sequential reads were conducted of each subject's Technegas images.
In the first read, only views that matched the Xe-133 image views were presented and read, and assessments based on the matched views were used in the primary outcome measure.
Immediately following the commitment of those assessments, all Technegas image views were presented to the reader, and a second assessment of all the Technegas image views was made using the same ventilation scoring metric as described for the primary outcome measure.
The estimation of PA and its analyses were also the same as for the primary outcome measure.
|
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).
|
Percent Agreement Measuring Inter-observer Agreement
Time Frame: 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).
|
Percent agreement (PA) measuring inter-observer agreement between pairs of blinded readers for their ventilation scoring assessments within each of the three imaging groups: Xe-133, Technegas matched views, and Technegas all views.
For each image set, a reader scored 6 regions of the lungs according to a three-point scale: 0=absent ventilation, 1=decreased ventilation, 2=normal ventilation; agreement between a pair of readers' assessments was based on the agreement of their ventilation scores by subject and lung region.
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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).
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Kappa Statistics Between Pairs of Blinded Readers by Lung Region
Time Frame: 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).
|
By lung-region kappa statistics measuring inter-observer agreement between pairs of blinded readers for their ventilation scoring assessments within each of the three imaging groups: Xe-133, Technegas matched views, and Technegas all views.
For each image set, a reader scored 6 regions of the lungs according to a three-point scale: 0=absent ventilation, 1=decreased ventilation, 2=normal ventilation.
Kappa statistics for a pair of readers' assessments were derived from the frequencies of the cross-tabulation of the readers' ventilation scores by lung region.
Kappa statistics are an index of inter-observer agreement corrected for chance with possible values ranging from -1 to 1, where 1 represents perfect agreement.
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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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Edward M Aten, MD, Certus International, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
September 18, 2020
Study Completion (Actual)
November 23, 2020
Study Registration Dates
First Submitted
February 8, 2017
First Submitted That Met QC Criteria
February 13, 2017
First Posted (Actual)
February 16, 2017
Study Record Updates
Last Update Posted (Actual)
September 24, 2021
Last Update Submitted That Met QC Criteria
August 30, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CYC-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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