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临床试验/NCT05034146
NCT05034146招募中不适用

The Diagnostic Efficiency of 68Ga-FAPI PET/CT in Malignant Tumors

Zhongnan Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年2月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
The diagnostic sensitivity and specificity of 68Ga-FAPI PET/CT in the staging of malignant tumors

研究概览

简要总结

Fibroblast-activation protein (FAP) is a type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. FAP can be detected in various of malignant neoplasms and is associated to tumor cell migration, invasion, and angiogenesis. Recently, a novel molecular probe, gallium 68-labelled FAP inhibitor (68Ga-FAPI), has been developed and used for visualization of tumor stroma by targeting FAP. Recent studies show favorable diagnosis efficiency in a variety of tumors, especially in gastrointestinal cancer, but the previous studies were all small-sample data or case reports. Therefore, further large-size research is necessary to confirm the advantages of 68Ga-FAPI in various of malignant tumors.

详细描述

The morbidity and mortality of malignant tumors are increasing. It is one of the major diseases that affect human health. At present, the conventional imaging diagnosis methods of a variety of malignant tumors are mainly CT and MRI based on anatomical imaging. Different from traditional imaging methods to visually display the lesion, nuclear medicine molecular imaging can not only locate the tumor location, but also image the expression and activity of specific molecules and biological processes. This molecular imaging method integrating anatomy and function is a noninvasive imaging to realize the early diagnosis and differential diagnosis, curative effect evaluation and follow-up observation of a variety of tumors. Positron emission tomography/computed tomography (PET/CT) uses specific molecular probes to target tumor. It can provide detailed information about the biochemical changes of tumor tissues at the cellular and molecular levels. It has better sensitivity and specificity than conventional imaging methods. At present, the most commonly used imaging agent in clinic is 18F-fluorodeoxyglucose (18F-FDG). 18F-FDG PET/CT is a valuable imaging modality in the management of patients with malignant tumors, but it is not a specific imaging agent for tumor application. The physiological uptake of gastrointestinal tract, infected tissues, or inflammatory cells can cause high 18F-FDG uptake resulting in a significant increase of the false positive rate; in addition, some tumors including well-differentiated hepatocellular carcinoma, renal cell carcinoma, and gastric signet ring cell carcinoma have low 18F-FDG uptake resulting in a high false negative rate. Therefore, it is very important to develop new molecular probes for targeting tumor.

Fibroblast-activation protein (FAP) is a type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. FAP can be detected in various of malignant neoplasms and is associated to tumor cell migration, invasion, and angiogenesis. Recently, a novel molecular probe, gallium 68-labelled FAP inhibitor (68Ga-FAPI), has been developed and used for visualization of tumor stroma by targeting FAP. Recent studies show favorable diagnosis efficiency in a variety of tumors, especially in gastrointestinal cancer, but the previous studies were all small-sample data or case reports. Therefore, further large-size research is necessary to confirm the advantages of 68Ga-FAPI in various of malignant tumors.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteering to participate in clinical trial and sign an informed consent form Patients with suspected or confirmed malignant tumor

排除标准

  • Female patients plan to become pregnant within 6 months Pregnant and lactating women Patients are allergic to multiple drugs including test drug Patients have participated in other clinical trials in the past one month

研究组 & 干预措施

68Ga-FAPI PET/CT in malignant tumors

Experimental

Investigators select subjects from patients who have underwent whole-body 18F-FDG PET/CT scan for suspected or confirmed malignancy, or suspected recurrence and metastasis after treatment for malignant tumors, focusing on malignant tumors with low FDG uptake including glioma, hepatocellular carcinoma, renal cancer, gastrointestinal cancer, and peritoneal metastases. Then the subjects receive whole-body 68Ga-FAPI PET/CT scan with time interval of one to four week.

干预措施: 68Ga-FAPI (Drug)

68Ga-FAPI PET/CT in malignant tumors

Experimental

Investigators select subjects from patients who have underwent whole-body 18F-FDG PET/CT scan for suspected or confirmed malignancy, or suspected recurrence and metastasis after treatment for malignant tumors, focusing on malignant tumors with low FDG uptake including glioma, hepatocellular carcinoma, renal cancer, gastrointestinal cancer, and peritoneal metastases. Then the subjects receive whole-body 68Ga-FAPI PET/CT scan with time interval of one to four week.

干预措施: PET/CT (Device)

结局指标

主要结局

The diagnostic sensitivity and specificity of 68Ga-FAPI PET/CT in the staging of malignant tumors

时间窗: three years

Taking the pathology or clinical follow-up as gold standard, the sensitivity and specificity of 68Ga-FAPI PET/CT in detecting malignant tumor were calculated.

次要结局

  • Prognostic value of FAPI PET parameters in malignant tumors(From baseline to 1 year post-treatment)
  • FAPI PET for therapeutic response evaluation in malignant tumors(Within 1 week after completion of neoadjuvant or adjuvant therapy)
  • The connection between FAPI PET parameters and histopathological biomarkers.(Within 4 weeks of FAPI PET scan)

研究者

发起方
Zhongnan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yong He

principal investigator

Zhongnan Hospital

研究点 (1)

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