neuroendocrine neoplasms (NEN)
Conditions
Interventions
Gold Standard:In this study, the gold standard (reference standard) is the patients pathological results. Specifically, it refers to the diagnostic results obtained through pathological sectioning or
Index test:[¹8F]-DLL3 PET/CT Imaging
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subjects participate in this trial voluntarily and sign the informed consent form; 2. Age is >=18 years old and <=80 years old (based on the date of signing the informed consent form), and gender is not restricted; 3. Patients suspected of having neuroendocrine tumors but without pathological results; 4. The subjects obtained pathological results within 4 weeks after receiving \([ ^{18} ~F]\) -DLL3 PET/CT imaging; 5. Physical fitness status score is 0 - 1 point; 6. The expected survival time is more than 12 months; 7. Female subjects of childbearing age, male subjects, and the partners of male subjects agree to use reliable contraceptive measures (such as abstinence, sterilization surgery, contraceptive pills, injection of medroxyprogesterone acetate, or subcutaneous implant for contraception, etc.) within 6 months after the end of the last study drug infusion; 8. Be willing and able to comply with scheduled visits, diagnostic plans, clinical laboratory tests, and other experimental procedures.
Exclusion criteria
Exclusion criteria: 1. History of any other malignant tumor within the past 5 years; 2. Having used radionuclides previously and the interval from the administration time of this study is less than 10 physical half - lives; 3. Participating in or planning to participate in any drug or device clinical trial during the study period; 4. Unable to lie flat or remain still during a PET scan, or intolerance to PET scan; 5. Those with a history of fracture or anemia in the past one year; 6. Subjects with abnormalities in physical examinations, ECG, and clinical laboratory tests during the screening period, as determined by the investigator, who may affect safety or compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sensitivity;Accuracy rate;specificity; | — |
Countries
China
Contacts
Public ContactDong Mengjie
Peking University Shenzhen Hospital
Outcome results
None listed