NCT02864810

Safety, Pharmacokinetics, Biodistribution, and Diagnostic Performance of [18F]GP1 PET in Thromboembolism

A Phase 1, Open-label, Non-randomized, Single Center Study to Assess Safety, Pharmacokinetics, Biodistribution, Internal Radiation Dosimetry and Diagnostic Performance of [18F]GP1 Positron Emission Tomography in Subjects With Venous or Arterial Thromboembolism

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Asan Foundation · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

\[18F\]GP1 targets platelet GPIIb/IIIa receptor in thrombus. \[18F\]GP1 PET/CT imaging will noninvasively assess thrombus in whole body with good sensitivity with information of thrombus. Safety, pharmacokinetics, biodistribution, internal radiation dosimetry and diagnostic performance of \[18F\]GP1 will be assessed in all subjects.

Conditions

• Thromboembolism

Interventions

Type	Name	Description
DRUG	[18F]GP1	\[18F\]GP1 PET/CT imaging for detecting thromboembolism

Timeline

• Start date: 2016-08-04
• Primary completion: 2017-09-09
• Completion: 2017-09-09
• First posted: 2016-08-12
• Last updated: 2018-05-18

Locations

1 site across 1 country: South Korea