Kidney cancer
Conditions
Interventions
Gold Standard:PET/CT imaging
pathological diagnosis
Index test:18F-labeled carbonic anhydrase 9+ 68Ga-polypeptide nuclide molecular probe+ PET/CT
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.) Subjects voluntarily sign the informed consent form and can complete the trial according to the requirements of the protocol; 2.) Over 18 years old, male or female; 3.) Clinically diagnosed with urinary tumors such as kidney cancer, the diagnostic criteria refer to biopsy, and CAIX immunohistochemistry is positive; 4) At least two measurable solid lesions in the subject's body, which can be accurately and continuously measured by the modified RECIST criteria (version 1.1); 5.) ECOG score of 0-2; 6.) Laboratory indicators need to meet: a. ALT and AST shall not exceed 3 times of the upper limit of normal, and BUN and Cr shall not exceed 1.5 times of the upper limit of normal; b. Blood routine: 2*109/L= WBC=2*1010/L, PLT=80*109/L, Hb=80 g/L; c. Other routine examinations are within the normal range or deemed acceptable by medical technicians.
Exclusion criteria
Exclusion criteria: 1.) recovery from major trauma (including surgery) within 4 weeks prior to receiving medical technical treatment; 2.) Patients with systemic or local serious infections or other serious comorbidities; 3.) Patients with abnormal immune function or recent use of immunosuppressive or enhancers, including various vaccines; 4.) Patients with autoimmune diseases, including rheumatoid, etc.; 5.) inadequately controlled arrhythmias, including atrial fibrillation; 6.) Cardiac insufficiency (> New York Heart Association (NYHA) Class II criteria); 7.) Suffering from uncontrolled hypertension; 8.) Patients with a history of allergy to any component of the imaging agent, including antibodies, or allergic constitution; 9.) Subjects who are positive for syphilis, HBV, HCV, HIV; 10.) Male and female subjects of childbearing age who are unable to take effective contraceptive measures; 11.) Pregnant or lactating women; 12.) Patients with a history of psychiatric illness or related medical conditions; 13.) Patients who cannot or cannot undergo PET/CT scans; 14.) Other subjects who are considered by medical technicians to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation dose intensity in isolated kidneys;accuracy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity ;Specificity ;Positive predicative value; | — |
Countries
China
Contacts
Public ContactWanhai Xu; Kezheng Wang
Harbin Medical University Cancer Hospital
Outcome results
None listed