Bladder cancer
Conditions
Interventions
Gold Standard:Pathological diagnosis
Index test:Nectin-4 targeted PET/MR or PET/CT
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.Cancer patients: The participant or their legal representative must be able to sign and date the informed consent form. 2.Cancer patients: The participant must agree to comply with the study procedures and cooperate throughout the entire research process. 3.Cancer patients: Adult patients (aged 18 years or older), regardless of gender. 4.Cancer patients: Patients clinically suspected or diagnosed with malignant tumors such as bladder cancer, breast cancer, lung cancer, ovarian cancer, pancreatic cancer (supported by evidence including serum tumor markers, ultrasound, CT, MRI imaging data, and histopathological examination), and in generally good health. 5.Cancer patients: Meet specific laboratory test results. 6.Cancer patients: Women of childbearing potential must have used contraception for at least one month prior to screening and commit to using effective contraception throughout the study period and for a specified time after the study ends. 7.Cancer patients: Other predefined inclusion criteria. 8.Healthy volunteers: Fully understand and voluntarily sign informed consent. 9.Healthy volunteers: Adults (aged 18 to 70 years), regardless of gender. 10.Healthy volunteers: Male weight =50.0kg, female weight =45.0kg; Body mass index (BMI) in the range of 19.0 to 26.0kg/m2 (including the critical value). 11.Healthy volunteers: No history of chronic or serious diseases of cardiovascular, liver, kidney, respiratory, blood and lymphatic, endocrine, immune, psychiatric, neuromuscular, and gastrointestinal systems within three years, and good overall health. 12.Healthy volunteers: Vital signs and physical examination showed no abnormality. 13.Healthy volunteers: During the trial period and 6 months after the end of the trial, they did not plan to have children, voluntarily took effective contraceptive measures, and did not plan to donate sperm or eggs. 14.Healthy volunteers: Be able to communicate well with the researcher and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1.Cancer patients: Those who are unable to complete a PET/MR or PET/CT examination (including inability to lie down, claustrophobia, radiophobia, etc.). 2.Cancer patients: Patients with known hypersensitivity to Nectin-4 antibody fragment developers or synthetic excipients; fasting blood glucose level greater than 11.0 mmol/L prior to 18F-FDG injection. 3.Cancer patients: Patients during pregnancy or lactation. 4.Cancer patients: Persons with other factors that make participation in this test inappropriate. 5.Healthy volunteers: Any serious or unstable medical condition; Acute disease occurred before the study; Past or existing malignancies. 6.Healthy volunteers: Women during pregnancy or lactation. 7.Healthy volunteers: People who had undergone surgery within 6 months prior to the trial that the investigators judged to affect absorption, distribution, metabolism, and excretion. 8.Healthy volunteers: Use of any drugs (including prescription drugs, over-the-counter drugs, and Chinese herbs) in the 2 weeks prior to the trial. 9.Healthy volunteers: Participated in other studies involving radioactive materials (within the last 12 months). 10.Healthy volunteers: Any other factors that affect the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized uptake values assessment of region of interest; | — |
Secondary
| Measure | Time frame |
|---|---|
| Radioactivity in the blood and urine samples;Pathological sections of tumour tissue;Blood test, urine test,liver and kidney function and other biochemical indicators;Electrocardiography,ECG; | — |
Countries
China
Contacts
Public ContactXiaoli Lan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed