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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Cyclomedica Australia PTY Limited.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Cyclomedica Australia PTY Limited
ClinicalTrials.gov Identifier:
NCT01458639
First received: October 19, 2011
Last updated: August 27, 2012
Last verified: August 2012

October 19, 2011
August 27, 2012
August 2012
December 2013   (final data collection date for primary outcome measure)
  • Sensitivity of Technegas V/Q SPECT for the diagnosis of PE [ Time Frame: Prospective, 30 days follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01458639 on ClinicalTrials.gov Archive Site
  • Accuracy of Technegas V/Q SPECT and Xenon V/Q Planar imaging for diagnosis of PE [ Time Frame: prospective, 30 days follow-up. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.
Same as current
Not Provided
Not Provided
 
Compare Technegas Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging for Pulmonary Embolism
A Comparison of Technegas® Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging in Subjects Being Evaluated for Pulmonary Embolism

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).

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Pulmonary Embolism
  • Drug: Technegas V/Q SPECT
    Technegas Ventilation SPECT imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.
    Other Name: Technetium-99m (Tc-99m) labeled carbon particles
  • Drug: Xenon-133
    Xenon-133 Ventilation Planar imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.
    Other Name: Xe-133
  • Experimental: Technegas
    Technetium-99m (Tc-99m) labeled carbon particles; approximately 1.1 milliCuries of Technegas
    Intervention: Drug: Technegas V/Q SPECT
  • Active Comparator: Xenon-133
    Intervention: Drug: Xenon-133
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects will be enrolled in Cohort 1 if they meet the following requirements:

  1. Male or female, at least 18 years of age.
  2. Suspected of having PE and be a candidate for Xe-133 V/Q imaging.
  3. Willing and able to provide informed consent.
  4. Stable and able to undergo Xe-133 planar imaging, Technegas SPECT imaging, and planar/SPECT perfusion imaging and complete follow-up procedures.
  5. Willing and agree to complete study procedures, including follow-up safety assessments.
  6. Using adequate birth control, if female and fertile.
  7. If female, has a negative urine or serum pregnancy test.
  8. Agrees to return for a 24-hour and 30 day follow-up safety assessment.

Subjects will be enrolled in Cohort 2 if they meet the above criteria AND subject is likely to have pulmonary embolism based on one or more of the following:

  1. Wells Score of 7 or greater. Subjects with a Wells Score less than 7 may be enrolled in Cohort 2 if there is agreement between the investigator and the medical monitor that the subject is at high risk for PE.
  2. An abnormal D-dimer test.
  3. Positive Doppler ultrasound for DVT.
  4. CTA is positive for PE within 24 hours of this imaging study.

Exclusion Criteria:

Subject

  1. Has undergone imaging with Iodine-131 (I-131) within 30 days, Thallium-201 (Tl-201) or Indium-111 (In-111) within 10 days, Fluorine 18 (F-18) within 24 hours, or any other radiopharmaceutical not otherwise specified within 72 hours of this imaging study.
  2. Has previously undergone an imaging study with a Tc-99m agent, within 48 hours of this imaging study.
  3. Is a pregnant or lactating female.
  4. Has received Technegas in the past.
  5. Was previously enrolled in another investigational study or received an investigational drug within 30 days prior to dosing.
  6. Is hemodynamically unstable.
  7. Has received therapeutic dose of low molecular weight or unfractionated heparin within 24 hours prior to dosing or Tissue Plasminogen Activator (tPA) within 4 hours prior to dosing or has received treatment for PE between the time of a positive CTA, if performed, and Technegas V/Q SPECT imaging.
Both
18 Years and older
No
Contact: Karen Wolfe-Kerker, MS 636-519-1699
United States
 
NCT01458639
CYC-008
Yes
Cyclomedica Australia PTY Limited
Cyclomedica Australia PTY Limited
Not Provided
Study Director: Edward M Aten, MD Certus International, Inc.
Principal Investigator: Akash Sharma, MD Washington University Mallinckrodt Institute of Radiology
Principal Investigator: David Leung, MD, PhD Columbia University Medical Center, New York, NY
Cyclomedica Australia PTY Limited
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP