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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 : Recruiting
First Posted : February 16, 2017
Last Update Posted : November 29, 2018
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Sequential 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: Single (Outcomes Assessor)
Masking Description: Independent blinded readers will assess all ventilation scintigraphy images. Images will have all subject identifiers removed and will be re-identified with unique random code numbers that will be used to control the order in which images will be displayed for assessment.
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
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Active Comparator: Xe-133

Xe-133 ventilation planar scintigraphy, performed per site standard of care procedures for subject medical need.

Subjects will be administered approximately 10 to 30 millicurie (mCi) of Xe-133 by inhalation.

Drug: Xe-133
Xe-133 ventilation scintigraphy
Other Names:
  • Xenon-133
  • Xenon gas

Experimental: Technegas
Technegas ventilation planar scintigraphy Subjects will receive approximately 1.1 mCi of Technegas (Technetium-99m labeled carbon particles) by inhalation.
Drug: Technegas
Technegas ventilation scintigraphy
Other Name: Technetium-99m labeled carbon particles




Primary Outcome Measures :
  1. Blinded readers percent agreement for matching image views [ Time Frame: Approximately 1 year after completion of the trial. ]
    Percent agreement between Technegas and Xe-133 obtained from the blinded readers' ventilation assessments of matching image views


Secondary Outcome Measures :
  1. Safety assessed by number of participants with treatment emergent adverse events, based on comparison of pre and post Technegas administration changes in clinical laboratory values, vital signs, oxygen saturation and physical examination [ Time Frame: 24 hours post Technegas administration ]
    The number of participants with treatment emergent adverse events, based on comparison of pre and post Technegas administration changes in clinical laboratory values, vital signs, oxygen saturation and physical examination

  2. Blinded readers percent agreement for all image views collected [ Time Frame: Approximately 1 year after completion of the trial. ]
    Percent agreement between Technegas and Xe-133 obtained from the blinded readers' ventilation assessments of all image views collected

  3. Blinded readers percent agreement for images collected in subgroup of subjects with pleural effusion and without pleural effusion [ Time Frame: Approximately 1 year after completion of the trial. ]
    Percent agreement between Technegas and Xe-133 obtained from the blinded readers' ventilation assessments of image views collected in subgroup of subjects with pleural effusion and without pleural effusion

  4. Percent agreement measuring inter-observer agreement [ Time Frame: Approximately 1 year after completion of the trial. ]
    Percent agreement measuring inter-observer agreement between pairs of blinded readers for their Technegas ventilation scores and for their Xe-133 ventilation scores

  5. By lung-region kappa statistics [ Time Frame: Approximately 1 year after completion of the trial. ]
    By lung-region kappa statistics measuring inter-observer agreement between pairs of blinded readers for their Technegas ventilation scores and for their Xe-133 ventilation scores



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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, 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.

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


Contacts
Contact: Edward M Aten, MD 603-627-1212 eaten@certusintl.com

Locations
United States, Florida
Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
Mayo Clinic in Jacksonville, FL Not yet recruiting
Jacksonville, Florida, United States, 32224
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
United States, Missouri
Washington University Medical Center, Barnes-Jewish Hospital - Center for Advanced Medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Kettering Medical Center Withdrawn
Kettering, Ohio, United States, 45429
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Scott & White Medical Center Recruiting
Temple, Texas, United States, 76508
United States, Utah
University of Utah Health Science Center Not yet recruiting
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Cyclomedica Australia PTY Limited
Investigators
Study Director: Edward M Aten, MD Certus International, Inc.

Responsible Party: Cyclomedica Australia PTY Limited
ClinicalTrials.gov Identifier: NCT03054870     History of Changes
Other Study ID Numbers: CYC-009
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs