注册号:
Registration number:
ChiCTR2500113686 最近更新日期:
Date of Last Refreshed on:
2025-12-02 10:07:55 注册时间:
Date of Registration:
2025-12-02 00:00:00 注册号状态:
预注册Registration Status:
Prospective registration注册题目:
68Ga标记Claudin 18.2显影剂联合PET/CT用于胰腺癌显像的临床研究Public title:
Clinical study on the imaging of pancreatic cancer using 68Ga-labeled Claudin 18.2 imaging agent combined with PET/CT注册题目简写:English Acronym:研究课题的正式科学名称:
68Ga标记Claudin 18.2显影剂联合PET/CT用于胰腺癌显像的临床研究Scientific title:
Clinical study on the imaging of pancreatic cancer using 68Ga-labeled Claudin 18.2 imaging agent combined with PET/CT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:
蒋伟怡
研究负责人:
戴东 Applicant:
Jiang Weiyi
Study leader:
Dai Dong 申请注册联系人电话:
Applicant telephone:
+86 156 0213 6891
研究负责人电话:
Study leader's telephone:
+86 186 2200 0577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:
jwydyx724@163.com
研究负责人电子邮件:
Study leader's E-mail:
xiandao5502@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:
天津市河西区体院北环湖西路
研究负责人通讯地址:
天津市河西区体院北环湖西路Applicant address:
Huanhu West Road, Tiyuanbei, Hexi District, Tianjin, China
Study leader's address:
Huanhu West Road, Tiyuanbei, Hexi District, Tianjin, 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:
天津医科大学肿瘤医院Applicant's institution:
Tianjin Medical University Cancer Institute and Hospital研究负责人所在单位:
天津医科大学肿瘤医院Affiliation of the Leader:
Tianjin Medical University Cancer Institute and Hospital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:
E20251127
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:
天津市肿瘤医院医学伦理委员会Name of the ethic committee:
Tianjin Cancer Hospital Medical Ethics Committee伦理委员会批准日期:
Date of approved by ethic committee:
2025-10-24 00:00:00伦理委员会联系人:
刘美君Contact Name of the ethic committee:
Liu Meijun伦理委员会联系地址:
天津市河西区体院北环湖西路天津医科大学肿瘤医院科创中心三楼伦理办公室Contact Address of the ethic committee:
Ethics Office, 3rd Floor, Science and Innovation Center Tianjin Medical University Cancer Institute and Hospital Huanhu West Road, Tiyuanbei, Hexi District Tianjin, China伦理委员会联系人电话:
Contact phone of the ethic committee:
+86 185 0222 2975
伦理委员会联系人邮箱:
Contact email of the ethic committee:研究实施负责(组长)单位:
天津医科大学肿瘤医院Primary sponsor:
Tianjin Medical University Cancer Institute and Hospital研究实施负责(组长)单位地址:
天津市河西区体院北环湖西路Primary sponsor's address:
Huanhu West Road, Tiyuanbei, Hexi District, Tianjin, 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):
天津市
市(区县):
Country:
China
Province:
Tianjin
City:
单位(医院):
天津医科大学肿瘤医院
具体地址:
天津市河西区体院北环湖西路
Institution
hospital:
Tianjin Medical UnTianjin Medical University Cancer Institute and Hospitaliversity Cancer Hospital
Address:
Huanhu West Road, Tiyuanbei, Hexi District, Tianjin, China经费或物资来源:
苏州智核生物医药科技有限公司Source(s) of funding:
Suzhou Zenu Biotechnology Co., Ltd.研究疾病:
胰腺癌 Target disease:
pancreatic cancer研究疾病代码:Target disease code:研究类型:
干预性研究Study type:
Interventional study研究所处阶段:
探索性研究/预试验 Study phase:
0研究设计:
单臂 Study design:
Single arm 研究目的:
主要目的
考察68Ga-NODAGA-SNA014在胰腺癌患者中的安全耐受性特征;
考察68Ga-NODAGA-SNA014在胰腺癌患者中的PET显像特征
次要目的
探索68Ga-NODAGA-SNA014在胰腺癌患者中对CLDN18.2的靶向能力;
初步比较68Ga-NODAGA-SNA014及18F-FDG在胰腺癌患者中的诊断效能。 Objectives of Study:
main purpose
To investigate the safety and tolerability characteristics of 68Ga-NODAGA-SNA014 in patients with pancreatic cancer;
Examine the PET imaging characteristics of 68Ga-NODAGA-SNA014 in patients with pancreatic cancer
Secondary objective
Explore the targeting ability of 68Ga-NODAGA-SNA014 towards CLDN18.2 in patients with pancreatic cancer;
Preliminary comparison of the diagnostic efficacy of 68Ga-NODAGA-SNA014 and 18F-FDG in patients with pancreatic cancer.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.年龄18~75岁(包括边界值);
2.具有行为能力,且自愿参加本次临床研究,并签署知情同意书(ICF)者;
3.经组织病理学或细胞学证实为胰腺癌;或影像学或临床怀疑为胰腺癌,计划在入组后60天内进行肿瘤切除或组织活检,且患者须同意在术后提供足够且合适的肿瘤组织样本(福尔马林固定、石蜡包埋样本)供研究中心进行病理学检测;
4.未接受过针对该肿瘤的下列治疗:放射治疗(包括近距离放疗),系统性抗肿瘤药物(化疗、小分子靶向药、单抗类药物等),其他临床研究中的试验性治疗。Inclusion criteria
1. Age range: 18 to 75 years old (inclusive);
2. Individuals with behavioral capacity who voluntarily participate in this clinical study and sign the Informed Consent Form (ICF);
3. Confirmed as pancreatic cancer through histopathology or cytology; or suspected of having pancreatic cancer based on imaging or clinical findings, with plans to perform tumor resection or tissue biopsy within 60 days after enrollment, and the patient must agree to provide sufficient and appropriate tumor tissue samples (formalin-fixed, paraffin-embedded samples) for pathological testing by the research center after surgery;
4. The patient has not received the following treatments for the tumor: radiotherapy (including brachytherapy), systemic anti-tumor drugs (chemotherapy, small molecule targeted drugs, monoclonal antibody drugs, etc.), or other experimental treatments in clinical research.排除标准:
1.合并其他明确诊断的恶性肿瘤患者;
2.未控制的重度感染者,或伴随其他严重疾病者;
3.预期生存期≤3个月者;
4.妊娠或哺乳期患者,以及在本试验过程中拒绝采取适当避孕措施的育龄患者;
5.研究者判断不适宜参加本研究的患者。Exclusion criteria:
1. Incorporate other patients with clearly diagnosed malignant tumors;
2. Individuals with uncontrolled severe infections, or those accompanied by other serious illnesses;
3. Patients with an expected survival period of <=3 months;
4. Pregnant or lactating patients, as well as childbearing-age patients who refuse to take appropriate contraceptive measures during the trial;
5. Patients whom the researchers judged as unsuitable for participation in this study.研究实施时间:
Study execute time:
从
From
2025-09-01 00:00:00至
To
2026-09-01 00:00:00
征募观察对象时间:
Recruiting time:
从
From
2025-12-02 00:00:00
至
To
2026-09-01 00:00:00干预措施:
Interventions:
组别:
试验组
样本量:
12
Group:
Test group
Sample size:
干预措施:
68Ga-NODAGA-SNA014及18F-FDG PET-CT显像
干预措施代码:
Intervention:
68Ga-NODAGA-SNA014 and 18F-FDG PET-CT imaging
Intervention code:研究实施地点:
Countries of recruitment and research settings:
国家:
中国
省(直辖市):
天津市
市(区县):
Country:
China
Province:
Tianjin
City:
单位(医院):
天津医科大学肿瘤医院
单位级别:
三甲
Institution
hospital:
Tianjin Medical University Cancer Institute and Hospital
Level of the institution:
Tertiary A测量指标:
Outcomes:
指标中文名:
药物安全性
指标类型:
主要指标
Outcome:
Medication Safety
Type:
Primary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
PET显像特征
指标类型:
主要指标
Outcome:
PET Imaging Characteristics
Type:
Primary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
PET显像与免疫组化Claudin 18.2表达量的相关性
指标类型:
次要指标
Outcome:
The correlation between PET imaging and Claudin 18.2 expression levels as measured by immunohistochemistry (IHC)
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
诊断效能
指标类型:
次要指标
Outcome:
Diagnostic Efficacy
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:采集人体标本:
Collecting sample(s)
from participants:
标本中文名:
血液
组织:
Sample Name:
blood
Tissue:
人体标本去向
使用后销毁
说明
Fate of sample:
Destruction after use
Note:
标本中文名:
尿液
组织:
Sample Name:
Urine
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
75
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:
公开/Public盲法:Blinding:试验完成后的统计结果(上传文件):
点击下载Calculated Results after
the Study Completed(upload file):
download是否共享原始数据:
IPD sharing
否No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):
否The way of sharing IPD”(include metadata and
protocol,
If use web-based public database, please provide
the
url):
no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:
CRFData collection and Management (A
standard data collection and management system
include a CRF and an electronic data capture:
CRF数据与安全监察委员会:
Data and Safety Monitoring Committee:
暂未确定/Not yet注册人:
Name of Registration:
2025-12-02 10:07:36