Using a new PET scan to diagnose 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
This study is testing a new type of PET scan to see if it can help doctors better diagnose acute deep vein thrombosis in patients who show symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 19 Years to 79 Years |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04156230 on ClinicalTrials.gov |
What this trial studies
This phase 2 study evaluates the diagnostic validity of [18F]GP1 positron emission tomography/computed tomography (PET/CT) for detecting acute deep vein thrombosis in symptomatic patients. It involves an open-label, non-randomized design with approximately 63 participants who have a high likelihood of deep vein thrombosis based on clinical criteria. Patients will undergo [18F]GP1 PET/CT imaging after a baseline assessment, and the results will be compared to venous ultrasonography, which serves as the reference standard. The study aims to optimize imaging techniques and gather preliminary efficacy data on this novel PET tracer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 79 with a first episode of clinically suspected acute deep vein thrombosis within 14 days and a positive D-dimer test or a Wells score of 2 or higher.
Not a fit: Patients who do not meet the inclusion criteria or have contraindications to the imaging procedure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more accurate and reliable method for diagnosing acute deep vein thrombosis, improving patient outcomes.
How similar studies have performed: Other studies have shown promising results with similar imaging approaches, but this specific application of [18F]GP1 PET/CT is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * Female subject is pregnant or nursing. Exclusion of the possibility of pregnancy is made by one of the following: 1) woman is physiologically post-menopausal (cessation of menses for more than 2 years), or 2) woman is surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy). If the woman is of childbearing potential, a urine pregnancy test performed within 24 hours immediately prior to administration of \[18F\]GP1 has to be negative and the women is advised to apply contraceptive measures during her participation in this study. * Subject has concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer (e.g. congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic renal or hepatic disease) which could compromise participation in the study in the judgment of the investigator. * Subject is a relative of the investigator, student of the investigator or otherwise dependent. * Subject has been involved in another investigative clinical study involving administration of an investigational drug from preceding 4 weeks prior to the study 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 judgment of the investigator, might make collection of complete data difficult or impossible. * Additive-related precautions: This investigational product contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Where this trial is running
Seoul
- Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Dae Hyuk Moon, MD — Asan Medical Center
- Study coordinator: Jae Eun Kim, RN
- Email: kje0216@amc.seoul.kr
- Phone: +82-2-3010-4572
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.