patients requiring diagnosis or suspected of having ccRCC.
Conditions
Interventions
Index test:[18F]AlF-CAIX-N and [18F]FDG imaging.
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily participate in this trial and sign the informed consent form. 2. Age between 18 and 70 years (based on the date of signing the informed consent form), with no gender restrictions. 3. The main inclusion criteria for patients are those with pathologically confirmed ccRCC or those with clinical symptoms and other imaging findings suspicious of ccRCC that need clarification. 4. Expected survival time of more than 12 weeks. 5. Blood routine and liver and kidney function must meet the following standards: Blood routine: WBC >= 4.0×10^9/L or neutrophils >= 1.5×10^9/L, PLT >= 100×10^9/L, Hb >= 90g/L; PT or APTT <= 1.5 ULN; Liver and kidney function: T-Bil <= 1.5×ULN (upper normal limit), ALT/AST <= 2.5×ULN or <= 5×ULN (for liver metastasis patients), ALP <= 2.5×ULN (if bone or liver metastasis present, ALP <= 4.5×ULN); BUN <= 1.5×ULN, SCr <= 1.5×ULN. 6. Willing and able to comply with diagnostic plans, clinical laboratory tests, and other trial procedures.
Exclusion criteria
Exclusion criteria: 1. Critically ill patients; those with severe respiratory failure or airway obstruction caused by respiratory diseases. 2. Patients with contraindications for PET/CT scans, including but not limited to: uncontrolled elevated blood glucose levels; women in preconception, pregnancy, or breastfeeding periods; those known to be allergic to radiopharmaceuticals or their excipients (including those with a history of severe allergic reactions or allergies to the tested drug). 3. Patients who cannot tolerate or have not successfully completed previous clinical examinations. 4. Patients who have used radioactive isotopes and the interval between the previous use and the administration in this study is less than 10 physical half-lives. 5. Patients who, in the judgment of the investigator, are deemed unsuitable to participate in this study. 6. Patients with a second primary tumor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Accuracy;Specificity; | — |
Countries
China
Contacts
Public ContactHaibo Chen
Peking University Shenzhen Hospital
Outcome results
None listed