Conditions: Pulmonary Embolism
Keywords: Pulmonary embolism PE
Allocation: NON_RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 18
Healthy volunteers: no

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 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 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.

Arms:
arm 1: Technegas V SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles; approximately 1.1 milliCuries of Technegas, compared with the results of Xenon-133 ventilation scan arm 2: Xenon-133 ventilation Planar imaging compared with the results of the Technegas scan.

Interventions: intervention 1: Technegas V SPECT imaging intervention 2: Xenon-133 Ventilation Planar imaging
Intervention descriptions: intervention 1: Technegas V SPECT imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism. intervention 2: Xenon-133 Ventilation Planar imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.

Protocol document: