The first-in-human study of \[18F\]GP1 positron emission tomography/computed tomography (PET/CT) showed that \[18F\]GP1 is safe and promising novel PET tracer for imaging acute venous thromboembolism with favorable biodistribution and pharmacokinetics in patients. The goal of this phase 2 study is to evaluate whether \[18F\]GP1 PET/CT is sensitive and specific for the diagnosis of acute deep vein thrombosis in the appropriate patient population and clinical setting. This study will provide preliminary evidence of efficacy and expand the safety database in a larger group of patients who were suspected of having acute deep vein thrombosis. This study will further optimize image acquisition techniques, and develop methods and criteria by which \[18F\]GP1 PET/CT will be evaluated. Other critical questions about \[18F\]GP1 biodistribution including \[18F\]GP1 uptake in pulmonary and systemic arteries will be evaluated.
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Sensitivity and specificity of qualitative [18F]GP1 PET/CT interpretation for the diagnosis of patients with acute proximal deep vein thrombosis
Timeframe: within 7 days of [18F]GP1 PET/CT