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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Comparison of Technegas® Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging in Subjects Being Evaluated for Pulmonary Embolism

Brief Summary: Phase 3 within-subject trial of Technegas V/Q SPECT and Tc-99m macro-aggregated albumin (MAA) imaging compared to Xenon-133 V/Q planar and Tc-99m macroaggregate of albumin (MAA) imaging for the diagnosis of Pulmonary Embolism (PE).

Detailed Summary: This is a Phase 3 within-subject trial of Technegas Ventilation SPECT and Tc-99m MAA perfusion imaging compared to xenon (Xe-133) Ventilation Planar and Tc-99m MAA perfusion imaging for the diagnosis of PE. Diagnosis of PE provided by review of the subjects' documented clinical information after 30 days of follow-up. Primary assessments of efficacy will be based on an independent blind reads of the Technegas V/Q SPECT images by three different readers and the independent blind reads of Xe 133 V/Q planar images by three different readers.
Sponsor: Cyclomedica Australia PTY Limited

Current Primary Outcome:

• Sensitivity of Technegas V/Q SPECT for the Diagnosis of PE [ Time Frame: Prospective, 30 days follow-up ]
  Compared to the sensitivity of Xenon V/Q Planar imaging. "Truth" based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up.
• Specificity of Technegas V/Q SPECT for the Diagnosis of PE. [ Time Frame: Prospective, 30 days follow-up ]
  Compared to the specificity of Xenon V/Q Planar imaging. "Truth" based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Accuracy of Technegas V/Q SPECT and Xenon V/Q Planar Imaging for Diagnosis of PE [ Time Frame: prospective, 30 days follow-up. ]
  Accuracy of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.
• Positive Predictive Value (PPV) of Imaging for Diagnosis of PE [ Time Frame: Prospective, 30 days follow-up ]
  PPV of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.
• Negative Predictive Value (NPV) of Imaging for Diagnosis of PE [ Time Frame: Prospective, 30 days follow-up ]
  NPV of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.
• Likelihood Ratio for Diagnosis of PE [ Time Frame: Prospective, 30 days follow-up ]
  Likelihood ratios of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.
• Safety of Technegas in Patients With Possible PE [ Time Frame: Prospective, from enrollment through 30 days follow-up ]
  Safety will be assessed by the incidence of treatment emergence adverse events and changes in clinical laboratory measurements, blood pressure, oxygen saturation, physical examination and pulmonary examination before and after treatment.

Original Secondary Outcome:

• Accuracy of Technegas V/Q SPECT and Xenon V/Q Planar Imaging for Diagnosis of PE [ Time Frame: prospective, 30 days follow-up. ]
  Accuracy of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.
• Positive predictive value of imaging for diagnosis of PE [ Time Frame: Prospective, 30 days follow-up ]
  PPV of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.
• Negative predictive value of imaging for diagnosis of PE [ Time Frame: Prospective, 30 days follow-up ]
  NPV of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.
• Likelihood Ratio for Diagnosis of PE [ Time Frame: Prospective, 30 days follow-up ]
  Likelihood ratios of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.
• Safety of Technegas in Patients With Possible PE [ Time Frame: Prospective, from enrollment through 30 days follow-up ]
  Safety will be assessed by the incidence of treatment emergence adverse events and changes in clincal laboratory measurements, blood pressure, oxygen saturation, physical examination and pulmonary examination before and after treatment.

Information By: Cyclomedica Australia PTY Limited

Dates:
Date Received: October 19, 2011
Date Started: August 2012
Date Completion:
Last Updated: October 13, 2015
Last Verified: October 2015