18F-S2P PET Imaging in the Evaluation of Large Artery Atherosclerosis
2026年9月8日 更新者：First Affiliated Hospital of Zhejiang University
A Prospective Clinical Study of 18F-S2P-Targeted STAB2 Receptor PET Imaging in the Diagnosis of Large Artery Atherosclerosis
The aim of this study is to evaluate the lesion detection performance and safety of 18F-S2P positron emission tomography (PET) in patients with large-artery atherosclerosis.
研究概览
详细说明
Atherosclerotic lesions contain macrophages expressing stabilin-2 (STAB2), which can be targeted by 18F-S2P.
However, conventional vascular imaging modalities mainly reflect the anatomical characteristics of atherosclerotic lesions and have limited ability to assess plaque inflammatory activity, which may affect the identification and risk evaluation of vulnerable plaques.
In addition, routine vascular imaging lacks specific molecular biomarkers for evaluating plaque inflammation.
18F-S2P is a novel 18F-labeled peptide tracer targeting STAB2.
Preclinical data suggest that 18F-S2P has favorable biodistribution and lesion-targeting properties, with no apparent toxicity observed in animal studies.
Patients can undergo PET imaging 0.5 hours after injection without special preparation.
Our study will assess the safety profile, image quality, and lesion detection performance of 18F-S2P.
Patients with clinically suspected large-artery atherosclerosis will be enrolled in this study.
研究类型
介入性
注册 (估计的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Dilibire Adili
- 电话号码：86 19916941901
- 邮箱：12418731@zju.edu.cn
学习地点
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Zhejiang、中国
- The First Affiliated Hospital of Zhejiang University school of medicine
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接触：
- Dilibire Adili
- 电话号码：86 19916941901
- 邮箱：12418731@zju.edu.cn
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接触：
- Xinhui Su
- 电话号码：86 13806071262
- 邮箱：suxinhui@zju.edu.cn
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria
- Aged 40 to 80 years old;
- Clinically suspected large artery atherosclerosis;
- Able to understand and comply with all study requirements;
- Participants aged ≥65 years with full civil capacity may sign informed consent independently; those with limited civil capacity shall sign the informed consent together with their legal guardians.
Exclusion Criteria
- Pregnant or breastfeeding female patients;
- Patients with severe claustrophobia, radiophobia, mental disorders or primary emotional disorders;
- Abnormal laboratory indicators at screening: hemoglobin (Hb) <10 g/dL, white blood cell (WBC) <3×10^9/L, platelet (PLT) <90×10^9/L, or creatinine clearance (CrCl) <40 mL/min;
- Subjects received ionizing radiation outside this trial within the past year leading to an annual radiation exposure exceeding 50 mSv;
- Subjects received any investigational drugs or devices with unconfirmed safety/efficacy within one month before enrollment;
- Any condition judged by the principal investigator that may bring potential harm to participants during the trial.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：18F-S2P PET/CT in Large-Artery Atherosclerosis
Each patient receives a single intravenous injection of 18F-S2P 3.7 MBq/kg and undergoes PET/CT scan after 30 min post-injection.
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Patients with large-artery atherosclerosis receive 3.7 MBq/kg of 18F-S2P intravenously followed by PET/CT after 30 min of injection.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sensitivity of 18F-S2P PET/CT
大体时间：through study completion, an average of 1 year
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Sensitivity of 18F-S2P PET/CT for detecting inflammatory atherosclerotic plaques in patients with large-artery atherosclerosis
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through study completion, an average of 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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18F-S2P PET performance compared with conventional imaging
大体时间：up to 24 months
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Imaging performance of 18F-S2P PET/CT compared with carotid ultrasound
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up to 24 months
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18F-S2P PET performance compared with conventional imaging
大体时间：up to 24 months
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Imaging performance of 18F-S2P PET/CT compared with magnetic resonance angiography (MRA)
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up to 24 months
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Quantitative uptake parameters of 18F-S2P in atherosclerotic plaques
大体时间：through study completion, 3-4 years
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Evaluate 18F-S2P uptake parameters within atherosclerotic lesions
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through study completion, 3-4 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2029年9月1日
研究完成 (估计的)
2031年9月1日
研究注册日期
首次提交
2026年8月24日
首先提交符合 QC 标准的
2026年9月8日
首次发布 (实际的)
2026年9月11日
研究记录更新
最后更新发布 (实际的)
2026年9月11日
上次提交的符合 QC 标准的更新
2026年9月8日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.