CompletedPhase 2

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

South Korea52 participantsStarted 2020-01-13

Plain-language 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.

Who can participate

Age range

19 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 any race/ethnicity. * Patient has a first episode of clinically suspected acute deep vein thrombosis of 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 Wells score (≥ 2), or the D-dimer test is positive. * Subject underwent or is scheduled to undergo venous ultrasonography within 7 days of \[18F\]GP1 PET/CT: * Patient has Eastern Cooperative Oncology Group performance status of 0-2 at time of screening. Exclusion Criteria: * A subject is to be excluded from the study if he/she does not fulfill the inclusion criteria or display any of the following criteria. * Subject or subject's legally acceptable representative does not provide written informed consent. * Subject has a previous history of objectively diagnosed deep vein thrombosis or pulmonary embolism. * Subject has symptoms of acute deep vein thrombosis lasting for longer than 4 weeks 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 days before the administration of \[18F\]GP1. * Anticancer chemotherapy is scheduled to be given to subject before or within 24 hours after administration of \[18F\]GP1. * Fema…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity and specificity of qualitative [18F]GP1 PET/CT interpretation for the diagnosis of patients with acute proximal deep vein thrombosis

Timeframe: within 7 days of [18F]GP1 PET/CT

Trial details

NCT IDNCT04156230

SponsorDae Hyuk Moon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-13

View on ClinicalTrials.gov More Venous Thrombosis trials