DLL3-Targeted PET/CT in Small Cell Lung Cancer
2026年6月25日 更新者：The First Affiliated Hospital of Xiamen University
Delta-like Protein 3 (DLL3)- Targeted PET Imaging in Small Cell Lung Cancer
The objective of the study is to evaluate the diagnostic value of DLL3-targeted PET/CT in patients with suspected or histologically confirmed small cell lung cancer, and to compare with conventional imaging modalities.
研究概览
地位
招聘中
详细说明
This study is designed to investigate DLL3-targeted PET/CT as a noninvasive approach for detecting tumor lesions in patients with suspected or confirmed small cell lung cancer (SCLC).In this research, patients with SCLC or highly suspected recurrence detection underwent contemporaneous DLL3-targeted PET/CT and conventional imaging (such as CT, MRI or 18F-FDG) either for an initial assessment or for metastases or highly suspected recurrence detection.
Tumor uptake was quantified by the maximum standardized uptake value (SUVmax).
By correlating immunohistochemistry with tumor uptake of the DLL3-targeted tracer, the investigators will explore the feasibility of visualizing tumor DLL3 expression using DLL3-targeted PET.
The numbers of positive tumor lesions of conventional imaging and DLL3-targeted PET/CT were recorded by visual interpretation.
The diagnostic accuracy of DLL3-targeted was calculated and compared to conventional imaging.
研究类型
介入性
注册 (估计的)
20
阶段
- 不适用
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：Liang Zhao
- 电话号码：86 18818350620
- 邮箱：wzhaoliang01@163.com
研究联系人备份
- 姓名：Haojun Chen
- 邮箱：leochen0821@foxmail.com
学习地点
-
-
Fujian
-
Xiamen、Fujian、中国、361000
- 招聘中
- The First Affiliated Hospital of Xiamen University
-
接触：
- Liang Zhao
- 电话号码：86 18818350620
- 邮箱：wzhaoliang01@163.com
-
-
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:
- Adult patients (aged 18 years or older);
- Patients with suspected, newly diagnosed, and previously treated small cell lung cancer(supporting evidence may include imaging findings and pathology report);
- Serum ProGRP or NSE level ≥ 3 times the upper limit of normal;
- Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
- Estimated life expectancy of more than 3 months, as assessed by the investigator, and ability to comply with study procedures and scheduled visits;
Exclusion Criteria:
- The inability or unwillingness of the research participant or legal representative to provide written informed consent.
- Inability to complete PET/CT imaging.
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：DLL3靶向PET/CT
每名受试者接受一次静脉注射DLL3靶向探针，并在指定时间内进行PET/CT成像。
|
Participants will undergo DLL3-Targeted PET/CT imaging for the evaluation of tumor lesions.
Imaging findings will be compared with conventional imaging modalities as part of the study analysis.
|
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 |
|---|---|---|
|
DLL3靶向PET示踪剂在正常器官和全身的辐射吸收剂量
大体时间：1年
|
辐射剂量测定将在施用DLL3靶向示踪剂后，通过连续全身PET/CT成像进行计算。
将为主要器官生成时间-活度曲线，并使用标准内照射剂量测定软件（例如OLINDA/EXM）估算吸收剂量。
测量单位：吸收辐射剂量（mGy/MBq）。
|
1年
|
|
Number of Participants With Clinically Significant Abnormal Vital Signs After Administration of the DLL3-targeted Tracer
大体时间：1 day
|
Vital signs, including body temperature, pulse rate, respiratory rate, systolic blood pressure, and diastolic blood pressure, will be monitored before and after administration of the DLL3-targeted tracer. Participants with at least one clinically significant abnormality in vital signs after tracer administration, as determined by the investigator, will be reported. Unit of Measure: Participants |
1 day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation between tumor DLL3 expression assessed by immunohistochemistry (H-score) and tumor uptake of the DLL3-targeted PET tracer (SUVmax)
大体时间：Baseline
|
Tumor DLL3 expression will be quantified using immunohistochemistry (IHC) and reported as an H-score (range 0-300).
Tumor uptake of the DLL3-targeted PET tracer will be measured as maximum standardized uptake value (SUVmax) on PET/CT imaging.
The correlation between DLL3 IHC H-score and PET SUVmax will be analyzed to evaluate the feasibility of noninvasively visualizing and quantifying tumor DLL3 expression using DLL3-targeted PET imaging.
|
Baseline
|
|
Lesion detection rate of 68Ga-DLL3 PET/CT
大体时间：The number and proportion of primary and metastatic lesions detected by 68Ga-DLL3 PET/CT compared with conventional imaging modalities (CT, MRI, bone scintigraphy, or 18F-FDG PET/CT, as applicable).
|
The number and proportion of primary and metastatic lesions detected by 68Ga-DLL3 PET/CT compared with conventional imaging modalities (CT, MRI, bone scintigraphy, or 18F-FDG PET/CT, as applicable).
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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5月9日
初级完成 (估计的)
2028年5月31日
研究完成 (估计的)
2028年5月31日
研究注册日期
首次提交
2026年6月8日
首先提交符合 QC 标准的
2026年6月25日
首次发布 (实际的)
2026年7月1日
研究记录更新
最后更新发布 (实际的)
2026年7月1日
上次提交的符合 QC 标准的更新
2026年6月25日
最后验证
2026年5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.