Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
[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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]GP1 PET/CT imaging | Experimental | Maximally 10 patients with deep vein thrombosis, pulmonary embolism, or arterial thromboembolism, respectively will be enrolled in the study (plus replacements for drop-outs). Intravenous injection and PET/CT scanning of [18F]GP1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]GP1 | Drug | [18F]GP1 PET/CT imaging for detecting thromboembolism |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of thromboembolic focus/foci with [18F]GP1 PET/CT | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative assessment of [18F]GP1 uptake in thromboembolic focus/foci as measured by standardized uptake value (SUV) | 6 months | |
| Biodistribution and radiation dosimetry of [18F]GP1 as measured by SUV | 6 months |
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Foundation | Seoul | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30617563 | Derived | Chae SY, Kwon TW, Jin S, Kwon SU, Sung C, Oh SJ, Lee SJ, Oh JS, Han Y, Cho YP, Lee N, Kim JY, Koglin N, Berndt M, Stephens AW, Moon DH. A phase 1, first-in-human study of 18F-GP1 positron emission tomography for imaging acute arterial thrombosis. EJNMMI Res. 2019 Jan 7;9(1):3. doi: 10.1186/s13550-018-0471-8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biodistribution and radiation dosimetry of [18F]GP1 as measured by radiation doses per organ (μGy/MBq). | 6 months |
| Pharmacokinetics of [18F]GP1 as measured by area under the curve | 6 months |
| Pharmacokinetics of [18F]GP1 as measured by Cmax | 6 months |
| Pharmacokinetics of [18F]GP1 as measured by Tmax | 6 months |
| Pharmacokinetics of [18F]GP1 as measured by percent fraction | 6 months |
| Safety of [18F]GP1 as measured by the number of participants with adverse events and significant changes in vital signs, electrocardiogram, physical examination and laboratory data that are related to treatment. | Evaluation of safety of [18F]GP1 | 6 months |
| Correlation of [18F]GP1 activity with fibrinogen and platelet glycoprotein IIb/IIIa and P-selectin expression. | 6 months |