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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
Each subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging after 18F-FDG PET/CT scan during 2 days and 1 week.
Department of Gastric Surgery
Fuzhou, Fujian, China
Diagnostic efficacy for peritoneal carcinomatosis
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
Time frame: One month after surgery
Maximum standardized uptake value [SUVmax (for PET/CT only)] for peritoneal carcinomatosis
SUVmax of 68Ga-FAPI PET/CT for peritoneal carcinomatosis in comparison with 18F-FDG PET/CT
Time frame: One month after surgery
Predictive value for peritoneal carcinomatosis by using radiomic algorithm
Prediction value of three kinds of imaging examination for peritoneal carcinomatosis by using radiomic algorithm
Time frame: One month after surgery
Diagnostic efficacy for primary lesions
Sensitivity, specificity, accuracy, PPV and NPV of 68Ga-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT and abdominal enhanced CT
Time frame: One month after surgery
SUVmax (for PET/CT only) for primary lesions
SUVmax of 68Ga-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT
Time frame: One month after surgery
Diagnostic efficacy for metastatic lymph nodes
Sensitivity, specificity, accuracy, PPV and NPV of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT and abdominal enhanced CT
Time frame: One month after surgery
SUVmax (for PET/CT only) for metastatic lymph nodes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
72
SUVmax of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT
Time frame: One month after surgery
Correlation between the expression of fibroblast activation protein (FAP) and 68Ga-FAPI uptake in different pathological types of peritoneal carcinomatosis
Analyzing the correlation between the SUVmax of 68Ga-FAPI in peritoneal carcinomatosis with different pathological types and FAP identified by pathological examinations
Time frame: One month after surgery
Correlation between the expression of FAP and 68Ga-FAPI uptake in different pathological types of primary lesions
Analyzing the correlation between the SUVmax of 68Ga-FAPI in primary lesions with different pathological types and FAP identified by pathological examinations
Time frame: One month after surgery
Correlation between the expression of FAP and 68Ga-FAPI uptake in different pathological types of metastatic lymph nodes
Analyzing the correlation between the SUVmax of 68Ga-FAPI in metastatic lymph nodes with different pathological types and FAP identified by pathological examinations
Time frame: One month after surgery
Predictive value of conversion therapy efficacy
Predictive value of three kinds of imaging examination for gastric cancer in conversion therapy response assessment
Time frame: One month after surgery
1-year progression-free survival rate
The relationship between three kinds of imaging examination and the patient's 1-year progression-free survival rate
Time frame: 12 months
1-year progression patterns
The relationship between the three types of imaging examinations and the patient's 1-year progression patterns
Time frame: 12 months