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

NCT03054870 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: CYC-009
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 9

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.

Conditions

Lung Structure Determination

Keywords

pulmonary ventilation; ventilation scintigraphy

Outcome Measures

Primary Outcomes (1)

• Blinded Readers Percent Agreement (PA) for Matching Image Views

  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 Outcomes (3)

• Blinded Readers Percent Agreement (PA) for All Image Views

  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

  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).

• Kappa Statistics Between Pairs of Blinded Readers by Lung Region

  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).

Study Arms (1)

Xe-133 Followed by Technegas

OTHER

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; Drug: Technegas

Interventions

Xe-133 DRUG

Xe-133 ventilation scintigraphy

Also known as: Xenon-133, Xenon gas

Xe-133 Followed by Technegas

Technegas DRUG

Technegas ventilation scintigraphy

Also known as: Technetium-99m labeled carbon particles

Xe-133 Followed by Technegas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cyclomedica Australia PTY Limited: lead

Study Sites (9)

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Mayo Clinic in Jacksonville, FL

Jacksonville, Florida, 32224, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Washington University Medical Center, Barnes-Jewish Hospital - Center for Advanced Medicine

St Louis, Missouri, 63110, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Scott & White Medical Center

Temple, Texas, 76508, United States

Location

University of Utah Health Science Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Interventions

Xenon-133; Lasers, Gas; Technegas

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Limitations and Caveats

Unblinded analysis of imaging efficacy data was to be done at completion of study and all blinded readings. Due to the COVID-19 pandemic impact on enrollment, FDA recommended an unplanned interim analysis be performed using blind read data from 200 subjects. Interim analysis was done by independent 3rd party statistician and reviewed by a Data Efficacy Monitoring Committee (DEMC), which recommended termination of the study based on positive results. Sponsor agreed.

Results Point of Contact

• Title: James McBrayer
• Organization: Cyclomedica Australia Pty Ltd

clinicaltrials@cyclomedica.com

+61 2 9541 0411

Study Officials

• Edward M Aten, MD

  Certus International, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will undergo standard of care Xe-133 ventilation scintigraphy per medical needs followed by investigational Technegas ventilation scintigraphy per protocol.

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 16, 2017
• Study Start: September 1, 2017
• Primary Completion: September 18, 2020
• Study Completion: November 23, 2020
• Last Updated: September 24, 2021
• Results First Posted: September 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)