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 range19 Years
SexALL
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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…
What they're measuring
1
Detection rate of thromboembolic focus/foci with [18F]GP1 PET/CT