Malignant tumors such as gastric cancer, pancreatic cancer and cholangiocarcinoma with CLDN18.2 expression have been clinically diagnosed or highly suspected
Conditions
Interventions
Gold Standard:Using biopsy/postoperative histopathology as the gold standard
Index test:CLDN18.2 PET imaging
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Tumor subjects:; (1)The subject or his legal agent can sign the name and date of the informed consent book; (2) Promise to abide by the research procedures and cooperate with the whole process of research; (3) Adult subjects (over 18 years old), regardless of gender; (4) Patients with malignant tumors such as gastric adenocarcinoma, pancreatic cancer, bile duct carcinoma, esophageal adenocarcinoma, etc. are clinically suspected or confirmed (supporting evidence includes serum-related tumor markers, ultrasound, CT, MRI and other imaging materials and histological pathological examination, etc.), and generally in good condition; (5) Meet the specific laboratory inspection results; (6) Female contraception before screening during the reproductive period should be used for at least one month, and promise to take contraception throughout the study period and continue until the time specified after the end of the study; (7) Other selection criteria are set. 2.Healthy subjects:; (1)Fully understand and voluntarily sign the informed consent form; (2) Men and women are not limited, 18-70 years old; (3) Male weight >=50.0kg, female weight >=45.0kg; body mass index (BMI) is in the range of 19.0~26.0kg/m^2 (including critical value); (4) No history or serious diseases of cardiovascular, liver, kidney, respiratory, blood and lymph, endocrine, immune, mental, neuromuscular, gastrointestinal system and other chronic diseases or serious diseases within three years, and the overall health is good; (5) There is no abnormality in vital sign examination and physical examination; (6) There is no fertility plan and effective contraceptive measures voluntarily during the trial period and within 6 months after the end of the trial, and there is no plan for sperm donation and egg donation; (7) Those who can communicate well with researchers and understand and abide by the requirements of this research.
Exclusion criteria
Exclusion criteria: 1.Tumor subjects:; (1)Those who cannot complete PET/MR or PET/CT examination (including those who cannot lie flat, claustrophobia, radiation phobia, etc.); (2) Patients who are known to be allergic to targeted CLDN18.2 PET imaging agents or synthetic excipients; the fasting blood glucose level exceeds 11.0 mmol/L before injection of [18F] FDG; (3) Patients who are pregnant or lactating; (4) Those who have other factors that are not suitable for participating in this test. 2.Healthy subjects:; (1) Any serious or unstable medical condition; acute diseases that occurred before the study; past or existing malignant tumors; (2) Pregnant and lactating women; (3) Those who have undergone surgery within 6 months before the trial that has been judged by researchers to affect absorption, distribution, metabolism and excretion; (4) Those who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicine) within 2 weeks before the trial; (5) Participated in other research involving radioactive substances (in the past 12 months); (6) Any other factors affecting the research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volume of the tumor;Region of Interest,ROI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood routine, liver and kidney function;Tumor markers; | — |
Countries
China
Contacts
Public ContactXiaoli Lan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed