Diagnostic Validity of [18F]GP1 PET for Diagnosing Acute Deep Vein Thrombosis
Status:
Recruiting
Trial end date:
2022-07-30
Target enrollment:
Participant gender:
Summary
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.