Esophageal cancer, gastric cancer, colorectal cancer, liver cancer, pancreatic cancer, cholangiocarcinoma, gallbladder cancer, small intestine cancer, etc.
Conditions
Interventions
Gold Standard:The reference criteria for the final diagnosis of primary, recurrent or metastatic lesions are biopsy or surgical pathological results, typical enhanced CT or MRI manifestations, or at l
Index test:68Ga-FAPI-04 PET/CT or PET/MR
PET-related parameters: standardized uptake value (SUV), SUVmax, SUVmean, and SUVpeak, tumor volume, total lesion FAP (fibroblast activation protein) activity.
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years; 2. Patients pathologically or clinically diagnosed with digestive system cancers (such as gastric cancer, colorectal cancer, pancreatic cancer, hepatocellular carcinoma, cholangiocarcinoma, etc.)
Exclusion criteria
Exclusion criteria: 1. Patients with malignant tumors other than digestive system cancers; 2. Patients diagnosed with digestive system cancers without confirmation through pathology or clinical follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized Uptake Value (SUV), Tumor Volume (TV), Total Lesion FAP Activity (TLFAP), Tumor-to-Liver Ratio (TLR), Tumor-to-Right Gluteus Maximus Ratio (TBR);Clinical Staging Value: T staging, N staging, M staging (sensitivity, specificity, accuracy, positive predictive value, negative predictive value);Treatment Response Assessment: Pathological Response (MPR/pCR);Prognostic Prediction: Overall Survival (OS), Progression-Free Survival (PFS);Correlation Metrics: Correlation between primary tumor FAPI uptake parameters (SUVmax, SUVpeak) and pathological T staging; correlation between regional lymph node FAPI uptake parameters and pathological N staging or lymph node metastatic burden; correlation between distant metastasis and baseline highest FAPI uptake (e.g., maximum whole-body SUVmax) or FAPI uptake parameters in specific organs (e.g., liver, peritoneum);Treatment Response Prediction Model Parameters: Baseline PET parameters (SUVmax, TV, TLFAP), ?PET parameters (e.g., ?%SUVmax), clinical-pathological factors (tumor location, differentiation grade, baseline CEA/CA19-9, etc.);Risk Stratification System: Risk score formula constructed based on independent prognostic factors identified by Cox multivariate analysis (low, intermediate, high-risk groups); | — |
Countries
China
Contacts
Public ContactXiaoliang Chen
Chongqing University Cancer Hospital
Outcome results
None listed