Compare Technegas Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging for Pulmonary Embolism
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Intervention: Technegas V SPECT imaging; Xenon-133 Ventilation Planar imaging
Intervention description: Technegas V SPECT imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.; Xenon-133 Ventilation Planar imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.
Intervention MeSH terms: Xenon
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary embolism; PE

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).
    

Eligibility criteria:

        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.