NCT02864810已完成1 期
A Phase 1, Open-label, Non-randomized, Single Center Study to Assess Safety, Pharmacokinetics, Biodistribution, Internal Radiation Dosimetry and Diagnostic Performance of [18F]GP1 Positron Emission Tomography in Subjects With Venous or Arterial Thromboembolism
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Detection rate of thromboembolic focus/foci with [18F]GP1 PET/CT
研究概览
简要总结
[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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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]GP
- •Patient has thromboembolic focus/foci confirmed by standard imaging modalities within 5 days prior to administration of [18F]GP
- •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
排除标准
- •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 24 hours after administration of [18F]GP
- •Female patient is pregnant or nursing.
- •Patient 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.
- •Patient is a relative of the investigator, student of the investigator or otherwise dependent.
- •Patient has been involved in another investigative clinical study involving administration of an investigational drug from preceding 4 weeks before to 24 hours after administration of [18F]GP
- •Patient has been previously included in this study.
- •Patient 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.
研究组 & 干预措施
[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
干预措施: [18F]GP1 (Drug)
结局指标
主要结局
Detection rate of thromboembolic focus/foci with [18F]GP1 PET/CT
时间窗: 6 months
次要结局
- Biodistribution and radiation dosimetry of [18F]GP1 as measured by SUV(6 months)
- Pharmacokinetics of [18F]GP1 as measured by area under the curve(6 months)
- 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 radiation doses per organ (μGy/MBq).(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.(6 months)
- Correlation of [18F]GP1 activity with fibrinogen and platelet glycoprotein IIb/IIIa and P-selectin expression.(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Diagnostic Validity of [18F]GP1 PET for Diagnosing Acute Deep Vein ThrombosisVenous ThrombosisNCT04156230Dae Hyuk Moon52
已完成
不适用
18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve ThrombosisThrombosis CardiacAortic Valve DiseaseNCT04073875University of Edinburgh53
已完成
不适用
In-vivo Thrombus Imaging With 18F-GP1, a Novel Platelet PET RadiotracerThrombosisAtherothrombosisNSTEMI - Non-ST Segment Elevation MIDVTMyocardial InfarctionProsthetic Valve ThrombosisPETStrokeTransient Ischemic AttackSTEMIPulmonary EmbolismNCT03943966University of Edinburgh73
招募中
1 期
Phase I Clinical Study of GC012F Injection in Treatment of Refractory Systemic Lupus ErythematosusCAR-TNCT05846347Zhejiang University15
已完成
2 期
Diagnostic Validity of [18F]FSPG PET for the Assessment of Acute Rejection After Heart or Liver TransplantationGraft RejectionHeart TransplantationLiver TransplantationNCT04488094Asan Medical Center7