Safety, Pharmacokinetics, Biodistribution, and Diagnostic Performance of [18F]GP1 PET in Thromboe… (NCT02864810) | Clinical Trial Compass
CompletedPhase 1
Safety, Pharmacokinetics, Biodistribution, and Diagnostic Performance of [18F]GP1 PET in Thromboembolism
South Korea32 participantsStarted 2016-08-04
Plain-language 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.
Who can participate
Age range
19 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:
* Patient is ≥ 19 years of age and male or female of any race/ethnicity.
* Patient has signs or symptoms of acute DVT of the leg, acute PE or ATE; or had arterial intervention or surgery, such as endovascular abdominal aortic aneurysm repair preferably within 14 days prior to the planned study with \[18F\]GP1.
* Patient has thromboembolic focus/foci confirmed by standard imaging modalities within 5 days prior to administration of \[18F\]GP1.
* Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at time of screening.
* Patient has clinical laboratory tests that are within the following ranges, determined within 7 days prior to administration of \[18F\]GP1:
* White blood cell count ≥ 3.0 x 109/L;
* Platelets ≥ 75.0 x 109/L;
* ALT and AST ≤ 3.0 times upper limit of normal;
* Bilirubin ≤ 1.5 times upper limit of normal; and
* Serum creatinine ≤ 1.5 times upper limit of normal
Exclusion Criteria:
A patient will be excluded from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:
* Patient or patient's legally acceptable representative does not provide written informed consent.
* In case of acute DVT or PE, patient has a previous history of objectively diagnosed DVT or PE.
* Patient had pretreatment with glycoprotein IIb/IIIa inhibitors within 15 days before the administration of \[18F\]GP1
* Chemotherapy is scheduled to given to patient before or within…
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
1
Detection rate of thromboembolic focus/foci with [18F]GP1 PET/CT