Status:
TERMINATED
Compare Technegas Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging for Pulmonary Embolism
Lead Sponsor:
Cyclomedica Australia PTY Limited
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 diagno...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Subjects will be enrolled in Cohort 1 if they meet the following requirements:
- Male or female, at least 18 years of age.
- Suspected of having PE and be a candidate for Xe-133 V/Q imaging.
- Willing and able to provide informed consent.
- Stable and able to undergo Xe-133 planar imaging, Technegas SPECT imaging, and planar/SPECT perfusion imaging and complete follow-up procedures.
- Willing and agree to complete study procedures, including follow-up safety assessments.
- Using adequate birth control, if female and fertile.
- If female, has a negative urine or serum pregnancy test.
- 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:
- 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.
- An abnormal D-dimer test.
- Positive Doppler ultrasound for DVT.
- CTA is positive for PE within 24 hours of this imaging study.
Exclusion
- Subject
- 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.
- Has previously undergone an imaging study with a Tc-99m agent, within 48 hours of this imaging study.
- Is a pregnant or lactating female.
- Has received Technegas in the past.
- Was previously enrolled in another investigational study or received an investigational drug within 30 days prior to dosing.
- Is hemodynamically unstable.
- 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.
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01458639
Start Date
August 1 2012
End Date
June 1 2015
Last Update
November 10 2015
Active Locations (2)
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1
Barnes-Jewish Hospital, Washington University
St Louis, Missouri, United States, 63110
2
Columbia University Medical Center
New York, New York, United States, 10032