A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer
A Clinical Study on the Safety and Tolerability, Biodistribution, Radiation Dosimetry, and Diagnostic Efficacy of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer
Primary Objective:
To evaluate the safety and tolerability of PET imaging following a single intravenous infusion of [⁶⁸Ga]Ga-ELI421 injection in patients with prostate cancer.
Secondary Objectives:
To evaluate the biodistribution characteristics of [⁶⁸Ga]Ga-ELI421 injection; To evaluate the radiation dosimetry characteristics of [⁶⁸Ga]Ga-ELI421 injection; To evaluate the diagnostic efficacy of PET imaging with [⁶⁸Ga]Ga-ELI421 injection.
研究概览
研究类型
介入性
注册 (估计的)
50
阶段
- 阶段2
- 阶段1
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：Xiaoli Lan
- 电话号码：+86-2783692633
- 邮箱：hzslxl@163.com
学习地点
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Hubei
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Wuhan、Hubei、中国、430000
- 招聘中
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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接触：
- Chunxia Qin
- 电话号码：+86-27-83692633
- 邮箱：qin_chunxia@hust.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:
- Has been fully informed about the study and voluntarily provided written informed consent prior to initiation of any study-related procedures;
- Aged ≥ 18 years;
- In generally good condition with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Patients with histopathologically and/or cytologically confirmed prostate cancer;
- Has an indication for PSMA PET imaging;
- No clinically significant abnormal findings on physical examination, vital signs, laboratory tests, 12-lead ECG, or other examinations that may compromise subject safety or imaging results.
- Subjects of reproductive potential agree to refrain from pregnancy, sperm donation, and voluntarily use highly effective contraceptive methods (including by their partner) for 6 months after study drug administration, such as condoms, oral or injectable contraceptives, intrauterine devices (IUDs), etc.
Exclusion Criteria:
- Presence of comorbidities that may compromise subject safety or interfere with imaging results;
- Concomitant medications that may compromise subject safety or interfere with imaging results;
- Insufficient washout period following prior anti-tumor therapies (including cytotoxic chemotherapy, immunotherapy, radiotherapy, etc.), which may compromise subject safety or interfere with imaging results;
- Known hypersensitivity to ionizing radiation or alcohol, or hypersensitivity to [⁶⁸Ga]Ga-ELI421 injection or its excipients, or other history of severe allergic reactions;
- Inability to complete PET imaging as required;
- Any other conditions deemed inappropriate by the investigator for participation in this study.
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：Single Arm with Dual PET Imaging: ELI421 and PSMA PET for Prostate Cancer
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Administration Protocol: A single rapid intravenous bolus injection of [68Ga]Ga-ELI421 injection at a radioactivity dose of about 185 MBq (5 mCi), followed by catheter flushing with approximately 10 mL of 0.9% sterile normal saline.
Static scanning and/or dynamic scanning Whole-body PET Imaging will be performed.
PSMA PET imaging will be performed in accordance with routine clinical practice.
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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 |
|---|---|---|
|
Adverse Event (AE)
大体时间：Day1, Day2-3
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Any abnormality, medication, or treatment after dosing shall be documented as an adverse event and concomitant medication / non-pharmacological treatment.
All adverse events shall be followed up until resolution, stabilization or remission of symptoms, or until abnormal laboratory values return to normal, baseline or a stable state, or until a reasonable explanation is obtained (e.g., loss to follow-up, death).
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Day1, Day2-3
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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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Lesion uptake value
大体时间：Day1
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ROIs shall be delineated to calculate the percentage injected dose (%ID), mean standardized uptake value (SUVmean), and retention time of target organs/tissues at various scanning time points.
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Day1
|
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Absorbed dose
大体时间：Day1
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Absorbed dose of target organs/tissues and total-body effective dose.
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Day1
|
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Diagnostic performance
大体时间：Day1
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Diagnostic performance of [⁶⁸Ga]Ga-ELI421 for lesion detection compared with PSMA PET, including the number of lesions and diagnostic performance indicators such as accuracy, sensitivity, and specificity.
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Day1
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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 (实际的)
2026年6月8日
初级完成 (估计的)
2026年12月30日
研究完成 (估计的)
2026年12月30日
研究注册日期
首次提交
2026年7月1日
首先提交符合 QC 标准的
2026年7月1日
首次发布 (实际的)
2026年7月8日
研究记录更新
最后更新发布 (实际的)
2026年7月8日
上次提交的符合 QC 标准的更新
2026年7月1日
最后验证
2026年6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.
[68Ga]Ga-ELI421 injection的临床试验
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RenJi Hospital招聘中胃癌 | 胰腺癌 | 小肠癌 | 消化系统癌 | 结肠癌 | 肝癌 | 消化系统肿瘤 | 胆囊癌 | 恶性肿瘤 | 阑尾癌 | 食管癌 | 直肠癌 | 消化道癌 | 消化系统癌症 | 胆管癌中国
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First Affiliated Hospital of Fujian Medical University招聘中
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University Hospital, Brest尚未招聘
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RenJi Hospital招聘中宫颈癌 | 头颈癌 | 鼻咽癌 | 卵巢癌 | 肺癌 | 实体瘤 | 前列腺癌 | 胆管癌 | 膀胱癌 | 子宫内膜癌 | 甲状腺癌 | 肝癌 | 实体癌 | 尿路上皮癌中国
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Anhui Provincial Hospital招聘中
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Nantes University Hospital主动，不招人