Ga68-labeled Fibroblast Activation Protein Inhibitor-46 (Ga68-FAPI-46) PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Correlation of the Ga68-FAPI PET/CT derived PCI (peritoneal cancer index) score with the intraoperative PCI based on histopathology of resected specimen (the reference standard)
研究概览
简要总结
This is a prospective, phase II, non-randomized clinical imaging trial. Ga68-FAPI-46 is a novel radiotracer used in PET/CT imaging, targeting a protein of the tumor microenvironment called FAP (Fibroblast activation protein).
The aim of the study is to assess the accuracy of Ga68-FAPI-46 PET/CT for preoperative assessment of peritoneal carcinomatosis in colorectal and ovarian cancer.
详细描述
Fibroblast activation protein (FAP) is a type II transmembrane glycoprotein expressed on the surface of cancer-associated fibroblasts (CAFs) in the stroma of various tumor entities. Recently, radiolabeled molecules targeting the FAP, called FAP inhibitors (FAPI) labelled with Gallium-68, have been developed for molecular imaging with PET/CT (positron emission tomography/computed tomography). This radiotracer often presents a higher cancer lesion detectability than F18-FDG (fluorodeoxyglucose), partly thanks to its higher tumour-to-background ratio achieved by a low background activity, particularly in the brain, abdominal cavity and liver. These advantages have resulted in a superior sensitivity of Ga68-FAPI PET/CT over F18-FDG and higher SUV (standardized uptake value) in evaluating various types of cancer. In this context, Ga68-FAPI PET/CT seems promising to further study as a clinical imaging modality for preoperative assessment of peritoneal carcinomatosis.
In this study, the investigators correlate Ga68-FAPI PET/CT findings in terms of peritoneal involvement with intraoperative findings based on histopathology and try to find out how accurate Ga68-FAPI PET/CT is for the preoperative assessment of peritoneal carcinomatosis.
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
- •Histologically proven colorectal and ovarian cancer.
- •Known or suspected peritoneal metastases from the tumour of origin.
- •Scheduled for peritoneal complete cytoreductive surgery with curative intent with or without neoadjuvant chemotherapy.
- •ECOG (Eastern Cooperative Oncology Group) Performance status ≤
- •Signed written informed consent obtained before any study-specific screening procedures.
排除标准
- •Non-resectable extra-abdominal metastasis and/or >3 hepatic metastases on standard work-up
- •Known chronic inflammatory conditions including the intestinal system (eg. inflammatory bowel disease, Crohn's disease)
- •Pregnant and lactating women
- •Previous or concurrent malignancy diagnosed within the last 3 years except adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell skin cancer.
- •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
Correlation of the Ga68-FAPI PET/CT derived PCI (peritoneal cancer index) score with the intraoperative PCI based on histopathology of resected specimen (the reference standard)
时间窗: Through completion of post-surgical pathological examination, up to 2 years since the study initiation
Intraoperative PCI validated by histopathology performed on resected peritoneal metastases obtained during peritoneal cytoreductive surgery/explorative laparoscopy or laparotomy will be correlated with Ga68-FAPI PET/CT derived PCI.
次要结局
- Assessment of the impact of neoadjuvant chemotherapy on the FAPI expression of target lesions at baseline.(Through completion of post-neoadjuvant chemotherapy FAPI PET examination,up to 2 years since the study initiation)
- Comparison of PCI obtained with Ga68-FAPI PET/CT to the PCI calculated on standard preoperative imaging.(Through completion of imaging examinations, up to 2 years since the study initiation)