NCT04156230

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

A Phase 2, Open-label, Non-randomized, Single Center Study to Assess Diagnostic Validity of [18F]GP1 Positron Emission Tomography/Computed Tomography for Acute Deep Vein Thrombosis of the Lower Extremities in Symptomatic Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Dae Hyuk Moon · Academic / Other
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is an open label, non-randomized, single center, intervention study. An estimated 63 symptomatic subjects with a pretest score of deep vein thrombosis likely (Wells score ≥ 2) or a positive D-dimer test will receive \[18F\]GP1 PET/CT to evaluate the diagnostic validity of \[18F\]GP1 PET/CT for detecting deep vein thrombosis foci in lower extremities. The study comprises 3 periods: screening, treatment, and follow-up. The screening period starts with the patient's signature on the informed consent form and ends with assignment to treatment that is inclusion of the subject for treatment. The treatment period starts with baseline measurements, and ends with the last measurement/procedure on the day of intravenous injection of 250 MBq of \[18F\]GP1. The follow-up period contains the end-of-study interview. Key measurement is the PET/CT image acquisition about 120 minutes after the single injection of \[18F\]GP1 This study includes venous ultrasonography of deep vein thrombosis as a valid reference standard. \[18F\]GP1 PET/CT will be assessed qualitatively and quantitatively by three experienced readers. This study will be monitored regularly by a clinical research associate from the sponsor or a designated contract research organization. Data quality and study integrity will be assessed. The investigator will document the items that are required to evaluate the study in the subject files. Data required according to this protocol are to be recorded on the case report forms provided by the sponsor as soon as possible.

Conditions

• Venous Thrombosis

Interventions

Type	Name	Description
DRUG	[18F]GP1 positron emission tomography/computed tomography	A radioactive dose of 250 MBq of the study drug with a total quantity of ≤ 10 µg will be administered as slow intravenous bolus injection over up to 60 seconds. PET/CT examinations will be performed at 120 ± 15 min after the administration of \[18F\]GP1.

Timeline

• Start date: 2020-01-13
• Primary completion: 2025-08-13
• Completion: 2025-08-13
• First posted: 2019-11-07
• Last updated: 2025-08-24

Locations

1 site across 1 country: South Korea