中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500107668
最近更新日期： Date of Last Refreshed on：	2025-08-15 17:35:44
注册时间： Date of Registration：	2025-08-15 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	评价小分子成像探针18F-TSPF PET/CT 成像在非小细胞肺癌患者临床诊断及疗效监测中的应用研究
Public title：	The Clinical Study on the Application of the Small-Molecule Imaging Probe 18F-TSPF PET/CT in the Diagnosis and Therapeutic Monitoring of Non-Small Cell Lung Cancer.
注册题目简写：
English Acronym：
研究课题的正式科学名称：	评价小分子成像探针18F-TSPF PET/CT 成像在非小细胞肺癌患者临床诊断及疗效监测中的应用研究
Scientific title：	The Clinical Study on the Application of the Small-Molecule Imaging Probe 18F-TSPF PET/CT in the Diagnosis and Therapeutic Monitoring of Non-Small Cell Lung Cancer.
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：	牟兴宇	研究负责人：	付巍
Applicant：	Xingyu Mu	Study leader：	Fu Wei
申请注册联系人电话： Applicant telephone：	+86 133 4763 1119	研究负责人电话： Study leader's telephone：	+86 139 7738 5850
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：	138887664@qq.com	研究负责人电子邮件： Study leader's E-mail：	13977385850@126.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：	广西桂林市秀峰区乐群路15号	研究负责人通讯地址：	桂林市乐群路15号
Applicant address：	No. 15 Lequn Road, Xiufeng District, Guilin City, Guangxi, China.	Study leader's address：	No. 15 Lequn Road, Xiufeng District, Guilin City, Guangxi, 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：	桂林医学院附属医院
Applicant's institution：	The Affiliated Hospital of Guilin Medical University
研究负责人所在单位：	桂林医学院附属医院
Affiliation of the Leader：	The Affiliated Hospital of Guilin Medical University

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：	2025IITLL-34	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：	桂林医学院附属医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Affiliated Hospital of Guilin Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2025-05-29 00:00:00
伦理委员会联系人：	林婧
Contact Name of the ethic committee：	Lin Jing
伦理委员会联系地址：	桂林市乐群路15号
Contact Address of the ethic committee：	No. 15 Lequn Road, Xiufeng District, Guilin City, Guangxi, China.
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 773 363 8370	伦理委员会联系人邮箱： Contact email of the ethic committee：	513543349@qq.com

研究实施负责（组长）单位：

桂林医学院附属医院

Primary sponsor：

The Affiliated Hospital of Guilin Medical University

研究实施负责（组长）单位地址：

桂林市乐群路15号

Primary sponsor's address：

No. 15 Lequn Road, Xiufeng District, Guilin City, Guangxi, 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)：	广西壮族自治区	市(区县)：
Country：	China	Province：	Guangxi Zhuang Autonomous Region	City：
单位(医院)：	桂林医学院附属医院	具体地址：	桂林市乐群路15号
Institution hospital：	The Affiliated Hospital of Guilin Medical University	Address：	No. 15 Lequn Road, Xiufeng District, Guilin City, Guangxi, China.

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-raised

研究疾病：

非小细胞肺癌

Target disease：

Non-small cell lung 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：

其它

Study phase：

N/A

研究设计：

单臂

Study design：

Single arm

研究目的：

本项目合成并拟应用 18F-TSPF PET/CT 分子探针对非小细胞肺癌（NSCLC）受试者进行成像，并将结果与病理学或免疫组化结果对照，以评价其在非小细胞肺癌诊断与疗效监测中的准确性和敏感性。

Objectives of Study：

This project involves the synthesis and intended application of the 18F-TSPF PET/CT molecular probe for imaging in patients with non-small cell lung cancer (NSCLC), with the results compared to pathological or immunohistochemical findings to evaluate the accuracy and sensitivity of this method in the diagnosis and therapeutic monitoring of NSCLC.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1.Voluntarily participates in the clinical study; fully understands and is informed about the study, and personally signs the Informed Consent Form (ICF); willing and able to comply with all study procedures.
2.	Aged >= 18 years and <= 75 years at the time of signing the ICF.
3.	Patients with histologically or cytologically confirmed non-small cell lung cancer (NSCLC) who intend to undergo subsequent clinical treatment.
4.	At least one measurable lesion assessed by the Independent Radiology Review Committee (IRRC) according to RECIST version 1.1 criteria.
5.	At the time of screening, patients must provide unstained archived tumor tissue/cell sample slides or fresh biopsy specimens, with sufficient quantity and size to allow for laboratory analysis of c-Met expression levels. Note: It is recommended to provide tumor tissue samples fixed in formalin prior to the initial study imaging. Preferred samples include paraffin-embedded lung cancer tissue (preferred), FFPE lung cancer specimens, or newly cut unstained serial tissue sections (preferably mounted on adhesive slides). A corresponding pathology report must also be provided. Acceptable types of newly obtained specimens include surgical excision, core needle biopsy, excisional, incisional, punch, or forceps biopsy (fresh tissue is preferred). Samples obtained by fine-needle aspiration (i.e., those lacking intact tissue structure and providing only cell suspensions and/or smears), brushing samples, or cell pellets from pleural effusion are not accepted.
6.	An expected survival time of at least 3 months.
7.	Major organ functions are adequate, meeting the following criteria (within 14 days prior to the first imaging in this study, no transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) treatment was received): absolute neutrophil count (ANC) >=  1.5 x 10^9/L; white blood cell count (WBC) >=  4.0 x 10^9/L; platelet count (PLT) >=  100 x 10^9/L; hemoglobin (Hb) >=  90 g/L; total bilirubin (TBIL) <=  1.5 x upper limit of normal (ULN), for patients with Gilbert’s syndrome, total bilirubin <=  3 x ULN is acceptable; alanine aminotransferase (ALT) <=  2.5 x ULN, for patients with liver metastases <=  5.0 x ULN; aspartate aminotransferase (AST) <=  2.5 x ULN, for patients with liver metastases <=  5.0 x ULN; alkaline phosphatase (ALP) <=  2.5 x ULN, for patients with liver or bone metastases <=  5.0 x ULN; serum albumin >=  30 g/L; international normalized ratio (INR) <=  1.5; creatinine (Cr) <=  1.5 x ULN, if > 1.5 x ULN, creatinine clearance must be >=  50 ml/min (calculated by Cockcroft-Gault formula).

排除标准：

1. 准备进行或者既往接受过器官或骨髓移植的患者。
2. 需要临床干预的胸腔积液或心包积液，或腹水。
3. 已知或筛选期检查发现患有活动性中枢神经系统（CNS）转移和/或癌性脑膜炎患者。但允许以下受试者入组：①无症状性脑转移受试者（即没有脑转移灶引起的进行性中枢神经系统症状，不需要皮质类固醇，且病变大小≤1.5cm）可以参加，但需要作为疾病部位定期进行脑部影像学检查。②经治疗后的脑转移受试者，且脑转移病灶稳定至少2个月（需要脑转移治疗后间隔至少4周的2次影像学检查确定），没有新的或扩大的脑转移证据，且研究药物给药前3天停用类固醇。这个定义中稳定的脑转移应该在本研究首次成像前确定。
4. 手术和/或放疗未能根治性治疗的脊髓压迫的受试者需排除。
5. 首次成像前半年内发生过心肌梗塞、控制不良的心律失常（包括QTc间期男性≥450ms、女性≥470ms）（QTc间期以Fridericia公式计算）。
6. 按照NYHA标准Ⅲ～Ⅳ级心功能不全或心脏彩超检查：LVEF（左室射血分数）<50%。
7. 受试者存在不可控或症状性高钙血症（>1.5mmol/L离子钙或钙>12mg/dL或校正血清钙>ULN）。
8. 受试者存在CTCAE外周神经病变≥2级。
9. 人类梅毒感染、免疫缺陷病毒（HIV）感染。
10. 患有活动性肺结核病。
11. 乙型肝炎（HBsAg或HBcAb检查呈阳性，且HBV-DNA检查呈阳性者），丙型肝炎（HCV抗体检查呈阳性，且HCV-RNA检查呈阳性）。存在乙肝及丙肝共同感染的受试者（HBsAg或HBcAb检查呈阳性，且HCV抗体检查呈阳性）。
12. 受试者存在已知活动性或可疑自身免疫病。允许入组处于稳定状态，不需要全身免疫抑制剂治疗的受试者。
13. 已知对造影剂有过敏史。
14. 孕妇或哺乳期妇女。
15. 已知有精神类药物滥用或吸毒史。
16. 有相关穿刺禁忌症。
17. 经研究者判断，受试者有其它不适合本研究的其他情况存在。

Exclusion criteria：

1. Patients who are preparing for or have previously undergone organ or bone marrow transplantation. 2. Patients with pleural effusion, pericardial effusion, or ascites requiring clinical intervention. 3. Patients known to have or found during screening to have active central nervous system (CNS) metastases and/or carcinomatous meningitis are excluded. However, the following subjects are allowed to enroll: 1) Asymptomatic brain metastases patients (i.e., no progressive CNS symptoms caused by brain metastases, no need for corticosteroids, and lesion size <= 1.5 cm) may participate but require regular brain imaging as part of disease site monitoring. 2) Patients with treated brain metastases whose brain lesions have been stable for at least 2 months (confirmed by two imaging assessments at least 4 weeks apart after brain metastasis treatment), with no evidence of new or enlarged brain metastases, and who have discontinued corticosteroids at least 3 days prior to study drug administration. Stability of brain metastases must be confirmed before the first imaging in this study. 4. Subjects with spinal cord compression not amenable to curative treatment by surgery and/or radiotherapy must be excluded. 5. Patients who have experienced myocardial infarction or uncontrolled arrhythmia (including QTc interval >= 450 ms for males and >= 470 ms for females, calculated by Fridericia’s formula) within six months prior to the first imaging. 6. Heart failure classified as NYHA class III–IV or echocardiographic findings showing left ventricular ejection fraction (LVEF) < 50%. 7. Subjects with uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, or total calcium > 12 mg/dL, or corrected serum calcium above the upper limit of normal [ULN]). 8. Subjects with CTCAE peripheral neuropathy of grade >= 2. 9. Infection with human syphilis or human immunodeficiency virus (HIV). 10. Patients with active pulmonary tuberculosis. 11. Patients with hepatitis B virus infection (positive HBsAg or HBcAb and detectable HBV-DNA) or hepatitis C virus infection (positive HCV antibody and detectable HCV-RNA). Subjects with co-infection of hepatitis B and hepatitis C (positive HBsAg or HBcAb and positive HCV antibody) are also included. 12. Subjects with known active or suspected autoimmune diseases. However, subjects with stable conditions not requiring systemic immunosuppressive therapy are allowed to enroll. 13. Known history of allergy to contrast agents. 14. Pregnant or breastfeeding women. 15. Known history of psychiatric medication abuse or substance abuse. 16. Presence of contraindications to relevant biopsy procedures. 17. In the judgment of the investigator, the subject has other conditions that make them unsuitable for participation in this study.

研究实施时间：

Study execute time：

从 From 2025-08-18 00:00:00至 To 2026-08-18 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-08-18 00:00:00 至 To 2026-08-18 00:00:00

干预措施：

Interventions：

组别：	18F-TSPF	样本量：	50
Group：	18F-TSPF	Sample size：	50
干预措施：	18F-TSPF	干预措施代码：
Intervention：	18F-TSPF	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广西壮族自治区	市(区县)：
Country：	China	Province：	Guangxi Zhuang Autonomous Region	City：
单位(医院)：	桂林医学院附属医院	单位级别：	三级甲等
Institution hospital：	Institution	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	最大标准化摄取值	指标类型：	主要指标
Outcome：	SUVmax	Type：	Primary indicator
测量时间点：	每位患者将分别在给药后的1小时内进行全身PET/CT显像	测量方法：	使用图像后处理工作站进行测量
Measure time point of outcome：	Each patient will undergo whole-body PET/CT imaging within 1 hour after administration.	Measure method：	Measurements will be performed using an image post-processing workstation.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	NA	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	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:

不公开/Private

盲法：	无
Blinding：	None

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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Writing scientific papers
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：	病例记录表和PACS图像存储
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form and PACS image storage
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2025-08-15 17:35:34