ChiCTR2600124480 版本V1.1 版本创建时间2026/05/14 15:49:56 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600124480 

最近更新日期：

Date of Last Refreshed on：

 2026-05-13 09:16:51 

注册时间：

Date of Registration：

 2026-05-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

靶向CLDN18.2的PET显像在恶性肿瘤中的临床应用价值

Public title：

Clinical application of CLDN18.2 targeted PET imaging in malignant tumors

注册题目简写：

English Acronym：

研究课题的正式科学名称：

靶向CLDN18.2的PET显像在恶性肿瘤中的临床应用价值

Scientific title：

Clinical application of CLDN18.2 targeted PET imaging in malignant tumors

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

兰晓莉 

研究负责人：

兰晓莉 

Applicant：

Xiaoli Lan 

Study leader：

Xiaoli Lan 

申请注册联系人电话：

Applicant telephone：

 +86 27 85726685

研究负责人电话：

Study leader's
telephone：

+86 27 85726685

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 lxl730724@hotmail.com

研究负责人电子邮件：

Study leader's E-mail：

 hzslxl@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

中国湖北省武汉市江汉区解放大道1277号

研究负责人通讯地址：

中国湖北省武汉市江汉区解放大道1277号

Applicant address：

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, China

Study leader's address：

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

华中科技大学同济医学院附属协和医院

Applicant's institution：

Union Hospital, Tongji Medical College, Huazhong University

研究负责人所在单位：

华中科技大学同济医学院附属协和医院

Affiliation of the Leader：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 [2025]伦审字（0785）号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

华中科技大学同济医学院附属协和医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Union Hospital of Tongji Medical College Huazhong University of Science and Technology

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-08-05 00:00:00

伦理委员会联系人：

褚圆圆

Contact Name of the ethic committee：

Chu Yuanyuan

伦理委员会联系地址：

中国湖北省武汉市江汉区解放大道1277号

Contact Address of the ethic committee：

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 27 85726375

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 994877373@qq.com

研究实施负责（组长）单位：

华中科技大学同济医学院附属协和医院

Primary sponsor：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究实施负责（组长）单位地址：

中国湖北省武汉市江汉区解放大道1277号

Primary sponsor's address：

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北

市(区县)：

Country：

China

Province：

Hubei

City：

单位(医院)：

华中科技大学同济医学院附属协和医院

具体地址：

中国湖北省武汉市江汉区解放大道1277号

Institution
hospital：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address：

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, China

经费或物资来源：

自筹

Source(s) of funding：

Self-financing

研究疾病：

临床已确诊或高度怀疑表达CLDN18.2的胃癌、胰腺癌、胆管癌等恶性肿瘤  

Target disease：

Malignant tumors such as gastric cancer, pancreatic cancer and cholangiocarcinoma with CLDN18.2 expression have been clinically diagnosed or highly suspected

研究疾病代码：

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

诊断试验诊断准确性 

Study design：

Diagnostic test for accuracy 

研究目的：

本项目拟在临床已确诊或高度怀疑表达CLDN18.2的胃癌、胰腺癌、胆管癌等恶性肿瘤患者及健康志愿者中，应用靶向CLDN18.2的PET显像剂（以68Ga-NOTA-CLDN18.2抗体片段为例），开展一体化PET/MR或PET/CT显像研究，旨在实现以下目的： 恶性肿瘤患者：用于肿瘤的早期诊断、分期与治疗评估。通过与金标准病理结果对比，评估68Ga-CLDN18.2 PET显像在定位肿瘤病灶、判断病灶性质（良恶性）、明确转移范围等方面的诊断准确性；同时与18F-FDG PET进行对比分析，探索其在识别低代谢活性或FDG低摄取肿瘤中的优势，辅助制定更精准的治疗策略，并为CLDN18.2靶向治疗患者筛选提供依据。 健康志愿者：开展初步的药代动力学和安全性研究，明确68Ga-CLDN18.2显像剂在人体内的分布、代谢途径、排泄方式及潜在不良反应，为后续大规模临床应用和影像剂的注册转化奠定基础。  

Objectives of Study：

This project plans to apply a targeted CLDN18.2 PET imaging agent (taking 68Ga-NOTA-CLDN18.2 antibody fragment as an example) to conduct integrated PET/MR or PET/CT imaging studies in patients with malignant tumors such as gastric cancer, pancreatic cancer, bile duct cancer, etc. that have been clinically diagnosed or highly suspected to express CLDN18.2, as well as healthy volunteers. The aim is to achieve the following objectives: Malignant tumor patients: Used for early diagnosis, staging, and treatment evaluation of tumors. By comparing with the gold standard pathological results, evaluate the diagnostic accuracy of 68Ga-CLDN18.2 PET imaging in locating tumor lesions, judging the nature of lesions (benign or malignant), and defining the extent of metastasis; at the same time, compare and analyze it with 18F-FDG PET to explore its advantages in identifying tumors with low metabolic activity or low FDG uptake, assist in formulating more precise treatment strategies, and provide a basis for the selection of patients for CLDN18.2 targeted therapy. Healthy volunteers: Conduct preliminary pharmacokinetic and safety studies to clarify the distribution, metabolic pathways, excretion methods, and potential adverse reactions of 68Ga-CLDN18.2 imaging agent in the human body, laying the foundation for subsequent large-scale clinical applications and the registration transformation of imaging agents.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.肿瘤受试者：； (1)受试者或其法定代理人能够签署知情同意书签名及日期； (2)承诺遵守研究程序，并配合实施全过程研究； (3)成年受试者（年龄18岁以上），男女不限； (4)临床怀疑或确诊的胃癌、胰腺癌、胆管癌、食管癌等恶性肿瘤患者（支持证据包括血清相关肿瘤标志物、超声、CT、MRI等影像资料和组织学病理检查等），且一般状况良好； (5)符合特定的实验室检查结果； (6)生育期女性筛检前避孕至少一个月以上，并承诺整个研究期内采取避孕且持续到研究结束后规定的时间； (7)其他设定入选标准； 2.健康受试者：； (1)充分理解并自愿签署知情同意书； (2)男女不限，年龄18-70岁； (3)男性体重≥50.0kg，女性体重≥45.0kg；体重指数（BMI）在19.0~26.0kg/m^2范围内（包括临界值）； (4)三年内无心血管、肝脏、肾脏、呼吸、血液和淋巴、内分泌、免疫、精神、神经肌肉、胃肠道系统等慢性疾病史或严重疾病史，并且总体健康状况良好； (5)生命体征检查、体格检查无异常； (6)在试验期间及试验结束后6个月内无生育计划并自愿采取有效避孕措施且无捐精、捐卵计划； (7)能够和研究者进行良好的沟通，并且理解和遵守本项研究的各项要求者；

Inclusion criteria

1.Tumor subjects:; (1)The subject or his legal agent can sign the name and date of the informed consent book; (2) Promise to abide by the research procedures and cooperate with the whole process of research; (3) Adult subjects (over 18 years old), regardless of gender; (4) Patients with malignant tumors such as gastric adenocarcinoma, pancreatic cancer, bile duct carcinoma, esophageal adenocarcinoma, etc. are clinically suspected or confirmed (supporting evidence includes serum-related tumor markers, ultrasound, CT, MRI and other imaging materials and histological pathological examination, etc.), and generally in good condition; (5) Meet the specific laboratory inspection results; (6) Female contraception before screening during the reproductive period should be used for at least one month, and promise to take contraception throughout the study period and continue until the time specified after the end of the study; (7) Other selection criteria are set. 2.Healthy subjects:; (1)Fully understand and voluntarily sign the informed consent form; (2) Men and women are not limited, 18-70 years old; (3) Male weight >=50.0kg, female weight >=45.0kg; body mass index (BMI) is in the range of 19.0~26.0kg/m^2 (including critical value); (4) No history or serious diseases of cardiovascular, liver, kidney, respiratory, blood and lymph, endocrine, immune, mental, neuromuscular, gastrointestinal system and other chronic diseases or serious diseases within three years, and the overall health is good; (5) There is no abnormality in vital sign examination and physical examination; (6) There is no fertility plan and effective contraceptive measures voluntarily during the trial period and within 6 months after the end of the trial, and there is no plan for sperm donation and egg donation; (7) Those who can communicate well with researchers and understand and abide by the requirements of this research.

排除标准：

1.肿瘤受试者：； (1)无法完成PET/MR或PET/CT检查者（包括无法平卧、幽闭恐惧症、放射恐惧症等）； (2)已知对靶向CLDN18.2 PET显像剂或合成辅料过敏的患者；注射[18F]FDG前空腹血糖水平超过11.0 mmol/L； (3)妊娠期或哺乳期的患者； (4)具有其他不宜参加此试验因素者； 2.健康受试者：； (1)任何严重或不稳定的医疗状况；研究前发生急性疾病者；既往或现存的恶性肿瘤； (2)妊娠和哺乳期妇女； (3)试验前6个月内接受过经研究者判断会影响吸收、分布、代谢、排泄的手术者； (4)试验前2周内使用过任何药物（包括处方药、非处方药、中草药）者； (5)参与过其他涉及放射性物质的研究（在过去12个月内）； (6)任何其他影响研究结果的因素；

Exclusion criteria：

1.Tumor subjects:; (1)Those who cannot complete PET/MR or PET/CT examination (including those who cannot lie flat, claustrophobia, radiation phobia, etc.); (2) Patients who are known to be allergic to targeted CLDN18.2 PET imaging agents or synthetic excipients; the fasting blood glucose level exceeds 11.0 mmol/L before injection of [18F] FDG; (3) Patients who are pregnant or lactating; (4) Those who have other factors that are not suitable for participating in this test. 2.Healthy subjects:; (1) Any serious or unstable medical condition; acute diseases that occurred before the study; past or existing malignant tumors; (2) Pregnant and lactating women; (3) Those who have undergone surgery within 6 months before the trial that has been judged by researchers to affect absorption, distribution, metabolism and excretion; (4) Those who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicine) within 2 weeks before the trial; (5) Participated in other research involving radioactive substances (in the past 12 months); (6) Any other factors affecting the research results.

研究实施时间：

Study execute time：

从 From 2025-09-01 00:00:00至 To 2026-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-20 00:00:00 至 To 2026-08-31 00:00:00

诊断试验：

Diagnostic Tests：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：

以活检/术后组织病理学为金标准

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Using biopsy/postoperative histopathology as the gold standard

指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：

CLDN18.2 PET 显像

Index test:

CLDN18.2 PET imaging

目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）

临床确诊或高度怀疑胃腺癌、胰腺癌、胆管癌、食管腺癌等恶性肿瘤患者

例数:

Sample size:

50

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Patients with clinical diagnosis or high suspicion of malignant tumors such as gastric adenocarcinoma, pancreatic cancer, bile duct cancer, esophageal adenocarcinoma, etc.

容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：

胃或胰腺等部位其他占位性疾病

例数:

Sample size:

6

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

Other space-occupying diseases in the stomach or pancreas and other parts

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北 

市(区县)：

  

Country：

China

Province：

Hubei

City：

单位(医院)：

 华中科技大学同济医学院附属协和医院 

单位级别：

 三级甲等 

Institution
hospital：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血常规、肝肾功能

指标类型：

次要指标

Outcome：

Blood routine, liver and kidney function

Type：

Secondary indicator

测量时间点：

完成显像后

测量方法：

血检

Measure time point of outcome：

After completing the imaging

Measure method：

Blood test

指标中文名：

病灶体积

指标类型：

主要指标

Outcome：

Volume of the tumor

Type：

Primary indicator

测量时间点：

所选显像时间点

测量方法：

在图像中勾画

Measure time point of outcome：

Selected imaging time point

Measure method：

Sketch in the image

指标中文名：

感兴趣区

指标类型：

主要指标

Outcome：

Region of Interest，ROI

Type：

Primary indicator

测量时间点：

所选显像时间点

测量方法：

在图像中勾画

Measure time point of outcome：

Selected imaging time point

Measure method：

Sketch in the image

指标中文名：

肿瘤标志物

指标类型：

次要指标

Outcome：

Tumor markers

Type：

Secondary indicator

测量时间点：

显像前

测量方法：

血检

Measure time point of outcome：

Before imaging

Measure method：

Blood test

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

肿瘤组织

组织：

Sample Name：

Tumor tissue

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 70 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

原始数据不共享，部分数据会在论文发布后公开，预计2026/12/30，邮箱lxl730724@hotmail.com

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Original data is not shared, some data will be made public after the paper is published, expected on 2026/12/30, email lxl730724@hotmail.com

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

纸质的病例记录表以及电子数据采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Paper-based care record forms and electronic data collection and management system

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-05-13 09:16:41