68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma (NYHCC)
2026年5月14日 更新者：Peking Union Medical College Hospital
Study on the Clinical Application of GPC3-targeting 68Ga-NYM207 PET/CT in Hepatocellular Carcinoma
This is a prospective, single-center, single-arm, phase I/II study designed to evaluate (1) the safety, tolerability, and imaging characteristics of 68Ga-NYM207 (Phase A), and (2) the diagnostic performance of 68Ga-NYM207 in detecting hepatocellular carcinoma (HCC) (Phase B).
This study will provide critical insights into the performance of 68Ga-NYM207 PET/CT as a non-invasive imaging tool for the detection of HCC.
研究概览
详细说明
Each patient will receive a single intravenous dose of 68Ga-NYM096, followed by dedicated whole-body PET/CT imaging. Safety, tolerability and imaging characteristics of ⁶⁸Ga-NYM207 will be evaluated. Imaging interpretations and reference standards will be used to estimate the sensitivity and specificity of 68Ga-NYM207 PET/CT.
Patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.
研究类型
介入性
注册 (估计的)
100
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：Li Huo
- 电话号码：+86 18612672038
- 邮箱：huoli@pumch.cn
研究联系人备份
- 姓名：Wenjia Zhu
- 电话号码：+86 18614080164
- 邮箱：zhuwenjia_pumc@163.com
学习地点
-
-
-
Beijing、中国、100730
- Peking Union Medical College Hospital
-
-
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:
- ≥18 years of age and of either gender;
- Written informed consent provided for participation in the trial;
At least one of the following indications should be applied:
- scheduled for surgical resection or biopsy of the liver mass within one month;
- with a history of HCC, recurrence or metastasis during follow-up (based on histopathologic examination or typical appearance of imaging data including conventional imaging or 18F-FDG PET/CT scan);
- Willing and able to follow schedule visits, treatment plans and laboratory tests.
Exclusion Criteria:
- Pregnancy or lactation;
- Severe claustrophobia;
- On treatment with anti-tumor drugs targeting GPC3;
- Any condition deemed by the investigator to interfere with study results or increase participant risk.
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 |
|---|---|
|
实验性的：68Ga-NYM207 PET/CT
68Ga-NYM207 PET/CT Each patient will receive one dose of 68Ga-NYM207 by intravenous route.
Dedicated whole-body PET/CT imaging will be performed.
|
Participants will be administered a single, intravenous bolus of 68Ga-NYM207.
The recommended administered activity of 68Ga-NYM207 is 1.8-2.2
MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ge/68Ga generator.
For biodistribution and imaging characteristics evaluation, PET scans will be performed at 15min, 30min, 60min, and 120min after 68Ga-NYM207 administration.
For diagnostic performance study, the CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NYM207 administration.
|
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 |
|---|---|---|
|
Safety and tolerability after ⁶⁸Ga-NYM207 administration (Phase A)
大体时间：From study completion to 1 month after completion
|
Number of adverse events associated with administration of ⁶⁸Ga-NYM207 will be recorded.
|
From study completion to 1 month after completion
|
|
Binary reading of focal lesions identified on 68Ga-NYM207 PET/CT (Phase B)
大体时间：From study completion to 1 month after completion
|
Any focal accumulation in the lesion suspected of metastasis or recurrence that cannot be explained by physiologic uptake of68Ga-NYM207 will be interpreted as PET positive.
|
From study completion to 1 month after completion
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dosimetry of 68Ga-NYM207
大体时间：From study completion to 1 month after completion
|
OLINDA/EXM will be used to determine the absorbed dose and effective dose per patient.
|
From study completion to 1 month after completion
|
|
SUVmax of focal lesions identified on 68Ga-NYM207 PET/CT
大体时间：From study completion to 1 month after completion
|
Tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest (ROI) over the lesion using a threshold of 40% SUVmax.
|
From study completion to 1 month after completion
|
|
Tumor-to-background of focal lesions identified on 68Ga-NYM207 PET/CT
大体时间：From study completion to 1 month after completion
|
Surrounding tissue is the preferred background tissue.
Should not available, the blood pool should be designated as background tissue.
|
From study completion to 1 month after completion
|
|
Intensity of GPC3 staining of lesions with pathological results
大体时间：From study completion to 1 month after completion
|
The intensity of CAIX staining of operated renal lesions will be based on a 4-point scale from 0-3 according to the method of Bui et al, 2003
|
From study completion to 1 month after completion
|
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6月1日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2026年5月6日
首先提交符合 QC 标准的
2026年5月14日
首次发布 (实际的)
2026年5月15日
研究记录更新
最后更新发布 (实际的)
2026年5月15日
上次提交的符合 QC 标准的更新
2026年5月14日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- K10590
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Available upon request
IPD 共享时间框架
Within 2 years after the publication of the main results
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.