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临床试验/NCT04778345
NCT04778345Unknown不适用

Preoperative Abdominal Enhanced CT, 18F-FDG PET/CT and 68Ga-FAPI PET/CT to Detect Peritoneal Carcinomatosis in High-Risk Patients With Gastric Cancer: A Prospective, Single-Center, Comparative Study

Fujian Medical University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
72
试验地点
1
主要终点
Maximum standardized uptake value [SUVmax (for PET/CT only)] for peritoneal carcinomatosis

研究概览

简要总结

This study aims to explore the value of 68Ga-FAPI PET/CT in the diagnosis of gastric cancer peritoneal carcinomatosis in high-risk patients compared with conventional abdominal enhanced CT and 18F-FDG PET/CT. The patients with gastric adenocarcinoma (cT4/N+/M0-1) will be studied.

详细描述

After being informed about the study and potential risks, all patients giving written informed consent will receive 68Ga-FAPI PET/CT on the 2nd day to 1st week of 18F-FDG PET/CT. On PET/CT, omentum, peritoneum, and mesenteric lesions with increased radioactive uptake are defined as suspicious peritoneal carcinomatosis. The number of these positive lesions, the maximum standardized uptake value (SUVmax), median and range will be recorded. Subsequently, the patients will undergo laparoscopic exploration, and if radical resection is assessed, radical gastrectomy (D2 lymph node dissection) will be performed. If a radical resection is not feasible, for patients with peritoneal carcinomatosis detected, one metastasis will be taken for rapid frozen diagnosis. After the peritoneal carcinomatosis is confirmed, the metastases seen under laparoscopy will be matched with the suspicious peritoneal carcinomatosis on the three preoperative imaging examinations. The intraoperative findings are used as the gold standard to compare the detection efficiency of the three imaging examinations for peritoneal carcinomatosis. Patients with unresected tumors will receive 4 cycles of conversion therapy or neoadjuvant therapy. After the treatment, 18F-FDG PET/CT and 68Ga-FAPI PET/CT will be performed again. If necessary, patients will be subjected to a second laparoscopic exploration, and radical gastrectomy (D2 lymph node dissection) will be performed for appropriate patients. If a radical resection is still not feasible, for patients with peritoneal carcinomatosis detected, biopsy of metastases will be performed if necessary.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18 to 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • The clinical tumor stage before PET/CT scan was evaluated as cT4/N+/M0-1, according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition
  • Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
  • American Society of Anesthesiology score (ASA) class I, II, or III
  • Written informed consent

排除标准

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous abdominal inflammatory diseases (such as peritonitis, pancreatitis, cholecystitis, inflammatory bowel disease)
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • Forced expiratory volume in 1 second (FEV1)<50% of predicted values
  • History of allergy to tracer agents of PET/CT
  • History of allergy to contrast agents of CT

结局指标

主要结局

Maximum standardized uptake value [SUVmax (for PET/CT only)] for peritoneal carcinomatosis

时间窗: One month after surgery

SUVmax of 68Ga-FAPI PET/CT for peritoneal carcinomatosis in comparison with 18F-FDG PET/CT

Diagnostic efficacy for peritoneal carcinomatosis

时间窗: One month after surgery

Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) of 68Ga-FAPI PET/CT for peritoneal carcinomatosis in comparison with 18F-FDG PET/CT and abdominal enhanced CT

次要结局

  • 1-year progression-free survival rate(12 months)
  • SUVmax (for PET/CT only) for primary lesions(One month after surgery)
  • Correlation between the expression of FAP and 68Ga-FAPI uptake in different pathological types of primary lesions(One month after surgery)
  • Predictive value for peritoneal carcinomatosis by using radiomic algorithm(One month after surgery)
  • SUVmax (for PET/CT only) for metastatic lymph nodes(One month after surgery)
  • Predictive value of conversion therapy efficacy(One month after surgery)
  • Correlation between the expression of FAP and 68Ga-FAPI uptake in different pathological types of metastatic lymph nodes(One month after surgery)
  • Diagnostic efficacy for primary lesions(One month after surgery)
  • Diagnostic efficacy for metastatic lymph nodes(One month after surgery)
  • 1-year progression patterns(12 months)
  • Correlation between the expression of fibroblast activation protein (FAP) and 68Ga-FAPI uptake in different pathological types of peritoneal carcinomatosis(One month after surgery)

研究者

发起方
Fujian Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang-Ming Huang, Prof.

Professor

Fujian Medical University

研究点 (1)

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