The Role of FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases: Non-randomized Phase II Molecular Imaging Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The quantification of IHC staining for FAP-expressing CAFs measured in patient-derived tissue specimens
研究概览
简要总结
FAPI PET/CT molecular imaging represents a cutting-edge advancement in oncological imaging, particularly for the preoperative assessment of colorectal liver metastases (CRLM). Fibroblast activation protein inhibitors (FAPIs), which are the focus of this imaging modality, selectively target cancer-associated fibroblasts, a critical component of the tumor microenvironment. FAPI PET/CT could be useful in the detection of HGP (Histological Growth Pattern) and in the changes during neoadjuvant chemotherapy prior to surgery
详细描述
The tumor microenvironment (TME) plays an important role in tumor development and therapeutic response. The understanding of the TME components, especially cancer-associated fibroblasts (CAFs) remains limited. CAFs are among the most abundant and versatile components of the tumor stroma and they are implicated in all the hallmarks of cancer. They have a heterogenous phenotype within a single cell. Some CAFs may have immunosuppressive properties. In liver, there are two obvious physiological sources of CAFs: resident portal fibroblasts (PFs) and hepatic stellate cells (HSCs) . A recent study showed that based on the gene expression profile there are three major subsets of CAFs in colorectal primary tumors and in liver metastasis, including secretory CAFs, ECM-remodeling CAFs and contractile CAFs . In patients undergoing resection of colorectal liver metastasis (CRLMs) the histological growth patterns (HGP) reflect tumor biology and local infiltrating behavior . The HGPs of liver metastases reflect the ways in which cancer cells interact with the surrounding liver. The transition from one HGP to another could occur in patients with CRLM following systemic treatment .
FAPI PET/CT molecular imaging represents a cutting-edge advancement in oncological imaging, particularly for the preoperative assessment of colorectal liver metastases (CRLM). Fibroblast activation protein inhibitors (FAPIs), which are the focus of this imaging modality, selectively target cancer-associated fibroblasts, a critical component of the tumor microenvironment. FAPI PET/CT could be useful in the detection of HGP and in the changes during neoadjuvant chemotherapy prior to surgery
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years.
- •Liver metastasis on standard imaging for the initial assessment (MRI, FDG PET/CT)
- •Naïve for treatment or after neoadjuvant chemotherapy
- •Scheduled for liver metastasis resection
- •ECOG Performance status ≤
- •Signed written informed consent
排除标准
- •Non-resectable liver metastases
- •Pregnant and lactating women
- •Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.
结局指标
主要结局
The quantification of IHC staining for FAP-expressing CAFs measured in patient-derived tissue specimens
时间窗: from the enrollement to the surgery date, approximately 3 to 4 weeks
The quantification of FAP expression on FAPI PET/CT (SUVmax, SUVmean, MTV [metabolically active tumor volume], FAPI-TV [FAPI positive tumour load])
时间窗: From enrollment to surgery date, approximately 3 to 4 weeks
correlation between the value of FAPI PET/CT and the percent encapsulated, and the HGP scores (desmoplastic, replacement, pushing) of the liver metastasis
时间窗: from the enrollment to the anapathological analysis date,approximately 4 to 5 weeks
次要结局
- Correlation between FAPI PET/CT and FDG PET/CT parameters: (SUV max, SUVmean, metabolical volume)(from enrollment to the surgery date, approximately 3 to 4 weeks)
- Correlation between FAPI metabolical volume and MRI tumor volume(from enrollment to the surgery date, approximately 3 to 4 weeks)
