Diagnostic Validity of [18F]GP1 PET for Diagnosing Acute Deep Vein Thrombosis

Inclusion Criteria:

• A subject will be enrolled if he/she meets all of the following inclusion criteria.

• Subject is aged between 19 and 79 years and male or female of anyrace/ethnicity.

• Patient has a first episode of clinically suspected acute deep vein thrombosisof the lower extremity within 14 days prior to the planned [18F]GP1 PET/CT.

• The pretest probability for deep vein thrombosis is likely by two-level Wellsscore (≥ 2), or the D-dimer test is positive.

• Subject underwent or is scheduled to undergo venous ultrasonography within 7days of [18F]GP1 PET/CT:

• Patient has Eastern Cooperative Oncology Group performance status of 0-2 attime of screening.

Exclusion Criteria:

• A subject is to be excluded from the study if he/she does not fulfill the inclusioncriteria or display any of the following criteria.

• Subject or subject's legally acceptable representative does not provide writteninformed consent.

• Subject has a previous history of objectively diagnosed deep vein thrombosis orpulmonary embolism.

• Subject has symptoms of acute deep vein thrombosis lasting for longer than 4weeks at time of screening.

• Subject is suspected to have pulmonary embolism with shock or hypotension

• Subject had pretreatment with glycoprotein IIb/IIIa inhibitors within 15 daysbefore the administration of [18F]GP1.

• Anticancer chemotherapy is scheduled to be given to subject before or within 24hours after administration of [18F]GP1.

• Female subject is pregnant or nursing. Exclusion of the possibility ofpregnancy is made by one of the following: 1) woman is physiologicallypost-menopausal (cessation of menses for more than 2 years), or 2) woman issurgically sterile (has had a documented bilateral oophorectomy and/ordocumented hysterectomy). If the woman is of childbearing potential, a urinepregnancy test performed within 24 hours immediately prior to administration of [18F]GP1 has to be negative and the women is advised to apply contraceptivemeasures during her participation in this study.

• Subject has concurrent severe and/or uncontrolled and/or unstable medicaldisease other than cancer (e.g. congestive heart failure, acute myocardialinfarction, severe pulmonary disease, chronic renal or hepatic disease) whichcould compromise participation in the study in the judgment of theinvestigator.

• Subject is a relative of the investigator, student of the investigator orotherwise dependent.

• Subject has been involved in another investigative clinical study involvingadministration of an investigational drug from preceding 4 weeks prior to thestudy enrollment or within 24 hours after administration of [18F]GP1.

• Subject has been previously included in this study.

• Subject has any other condition or personal circumstances that, in the judgmentof the investigator, might make collection of complete data difficult orimpossible.

• Additive-related precautions: This investigational product contains sodiumbisulfite, a sulfite that may cause allergic-type reactions includinganaphylactic symptoms and life-threatening or less severe asthmatic episodes incertain susceptible people. The overall prevalence of sulfite sensitivity inthe general population is unknown and probably low. Sulfite sensitivity is seenmore frequently in asthmatic than in nonasthmatic people.