Malignant tumors
Conditions
Interventions
Gold Standard:The gold standard (reference standard) of this study is the pathological section of tissue specimens or the results of immunohistochemistry.
Index test:¹8F - FMISO 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. Aged >= 18 years and <= 80 years (based on the date of signing the informed consent form), regardless of gender. 3. Patients with suspected malignant tumors who have not yet obtained pathological results. 4. The subjects obtained pathological results within two weeks after undergoing \(^{18} ~F\) -FMISO 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 potential, male subjects, and the partners of male subjects agree to use reliable contraceptive measures (such as abstinence, sterilization surgery, contraceptive pills, injectable contraceptives like medroxyprogesterone acetate, or subcutaneous implant 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. Those who have used radionuclides in the past and the interval from the administration of the study drug 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. Known to be allergic to the injection or its excipients. 5. Unable to lie flat or remain still during a PET scan, or intolerant of PET scans. 6. Those with a history of fracture or anemia in the past year. 7. Subjects with abnormalities in physical examination, ECG and clinical laboratory tests during the screening period, which, as determined by the investigator, 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