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

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ClinicalTrials.gov Identifier: NCT03054870
Recruitment Status : Terminated (Trial met primary efficacy endpoint target. No additional subjects necessary.)
First Posted : February 16, 2017
Results First Posted : September 24, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Cyclomedica Australia PTY Limited

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.

Condition or disease Intervention/treatment Phase
Lung Structure Determination Drug: Xe-133 Drug: Technegas Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: N/A
Intervention Model: Crossover Assignment
Intervention Model Description: Subjects will undergo standard of care Xe-133 ventilation scintigraphy per medical needs followed by investigational Technegas ventilation scintigraphy per protocol.
Masking: None (Open Label)
Masking Description: Independent blinded readers will assess all ventilation scintigraphy images, masked as to subject identity and re-identified with a unique random code number (different code numbers for Xe-133 and Technegas images). The Xe-133 and Technegas images will be read in separate reading sessions in random order.
Primary Purpose: Other
Official Title: A Comparison of Technegas® and Xenon 133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : September 18, 2020
Actual Study Completion Date : November 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Xe-133
Xe-133 ventilation scintigraphy
Other Names:
  • Xenon-133
  • Xenon gas

Drug: Technegas
Technegas ventilation scintigraphy
Other Name: Technetium-99m labeled carbon particles




Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054870


Locations
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United States, Florida
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Mayo Clinic in Jacksonville, FL
Jacksonville, Florida, United States, 32224
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Missouri
Washington University Medical Center, Barnes-Jewish Hospital - Center for Advanced Medicine
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Houston Methodist Hospital
Houston, Texas, United States, 77030
Scott & White Medical Center
Temple, Texas, United States, 76508
United States, Utah
University of Utah Health Science Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Cyclomedica Australia PTY Limited
Investigators
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Study Director: Edward M Aten, MD Certus International, Inc.
  Study Documents (Full-Text)

Documents provided by Cyclomedica Australia PTY Limited:
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Responsible Party: Cyclomedica Australia PTY Limited
ClinicalTrials.gov Identifier: NCT03054870    
Other Study ID Numbers: CYC-009
First Posted: February 16, 2017    Key Record Dates
Results First Posted: September 24, 2021
Last Update Posted: September 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cyclomedica Australia PTY Limited:
pulmonary ventilation
ventilation scintigraphy
Additional relevant MeSH terms:
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Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs