Compare Technegas Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging for Pulmonary Embolism

This study has been terminated.
(Decision to change trial design.)
Sponsor:
Information provided by (Responsible Party):
Cyclomedica Australia PTY Limited
ClinicalTrials.gov Identifier:
NCT01458639
First received: October 19, 2011
Last updated: October 13, 2015
Last verified: October 2015
Results First Received: July 20, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Diagnostic
Condition: Pulmonary Embolism
Interventions: Drug: Technegas V SPECT imaging
Drug: Xenon-133 Ventilation Planar imaging

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was November 14, 2012 to June 11, 2014. Subjects were recruited from US medical centers that performed Xenon-133 ventilation scans to evaluate patients for pulmonary embolism (PE).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects suspected of PE to have Xe-133 ventilation/Tc-99m macroaggregated albumin (MAA) perfusion (VQ) scan. Must have at least one within 72 hours before imaging: D-dimer, Doppler ultrasound for deep vein thrombosis (DVT) or computed tomography angiography (CTA) for PE. Not have therapeutic dose blood thinner for > than 72 hrs prior to imaging.

Reporting Groups
  Description
Overall Study Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.

Participant Flow:   Overall Study
    Overall Study  
STARTED     18  
COMPLETED     12  
NOT COMPLETED     6  
Physician Decision                 4  
Equipment issue                 1  
Inability to obtain subject blood sample                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects enrolled in the trial.

Reporting Groups
  Description
Overall Study Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
  18  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     6  
Age  
[units: years]
Mean (Full Range)
  59.5  
  (34 to 81)  
Gender  
[units: participants]
 
Female     7  
Male     11  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     8  
Not Hispanic or Latino     10  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     8  
White     10  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     18  



  Outcome Measures
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1.  Primary:   Sensitivity of Technegas V/Q SPECT for the Diagnosis of PE   [ Time Frame: Prospective, 30 days follow-up ]

2.  Primary:   Specificity of Technegas V/Q SPECT for the Diagnosis of PE.   [ Time Frame: Prospective, 30 days follow-up ]

3.  Secondary:   Accuracy of Technegas V/Q SPECT and Xenon V/Q Planar Imaging for Diagnosis of PE   [ Time Frame: prospective, 30 days follow-up. ]

4.  Secondary:   Positive Predictive Value (PPV) of Imaging for Diagnosis of PE   [ Time Frame: Prospective, 30 days follow-up ]

5.  Secondary:   Negative Predictive Value (NPV) of Imaging for Diagnosis of PE   [ Time Frame: Prospective, 30 days follow-up ]

6.  Secondary:   Likelihood Ratio for Diagnosis of PE   [ Time Frame: Prospective, 30 days follow-up ]

7.  Secondary:   Safety of Technegas in Patients With Possible PE   [ Time Frame: Prospective, from enrollment through 30 days follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
PE adjudication by Independent Committee for final clinical diagnosis and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were not performed due to early trial termination. No efficacy data available.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gary Somerville, Quality and Regulatory Manager
Organization: Cyclomedica Australia Pty Ltd
phone: +61 (0)2 9541 0411
e-mail: gsomerville@cyclomedica.com.au



Responsible Party: Cyclomedica Australia PTY Limited
ClinicalTrials.gov Identifier: NCT01458639     History of Changes
Other Study ID Numbers: CYC-008
Study First Received: October 19, 2011
Results First Received: July 20, 2015
Last Updated: October 13, 2015
Health Authority: United States: Food and Drug Administration