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

Stopped early · Phase 3

Conditions studied: Pulmonary Embolism

In brief

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).

Key facts

Study ID

NCT01458639

Run by

Cyclomedica Australia PTY Limited

People needed

18

Starts

2012-08-01

Expected to finish

2015-06-01

Last updated by the study team

2015-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Barnes-Jewish Hospital, Washington University — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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