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

NCT04156230 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-08-24

No results posted yet for this study

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.

Conditions

  • Venous Thrombosis

Interventions

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.

Sponsors & Collaborators

  • Dae Hyuk Moon

    lead OTHER

Principal Investigators

  • Dae Hyuk Moon, MD · Asan Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2025-08-13
Completion
2025-08-13

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04156230 on ClinicalTrials.gov