Gastric Cancer
Conditions
Interventions
Gold Standard:Pathological findings from surgery or serial imaging surveillance
Index test:The safety of 68Ga-FAPI-RJ PET/CT imaging and a comparison of its diagnostic efficacy with 68Ga-FAPI-04 PET/CT in gastric cancer
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 80 years, inclusive; 2.Histopathologically confirmed gastric adenocarcinoma (including signet ring cell carcinoma) via gastroscopic biopsy; 3.cT1-4bN0-3M0-1 (according to the 8th edition UICC gastric cancer cTNM staging); 4.Willing to participate in this clinical trial and provide signed informed consent; 5.Good compliance, commitment to adhere to the study procedures, and cooperation throughout the entire study process; 6.No pregnancy plan within six months;
Exclusion criteria
Exclusion criteria: 1.Presence of severe conditions deemed by the investigator to render the subject unsuitable for participation in this clinical study, such as severe cardiopulmonary insufficiency, severe myelosuppression, or severe hepatic or renal dysfunction; 2.Severe psychiatric symptoms or impaired consciousness that preclude cooperation with the examination; 3.Pregnant women, women with potential for pregnancy, or lactating women; 4.Poor compliance;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AE); Incidence of Serious Adverse Events (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| PET parameters;Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy; | — |
Countries
China
Contacts
Public ContactLi Biao
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed