This is a prospective, open-label, single-center clinical study targeting renal cell carcinoma. Sixty patients with a high clinical suspicion of renal cell carcinoma were included. Qualified subjects will undergo 68Ga-NOTA-RCCB6 PET/CT examination. The aim is to establish the optimal imaging protocol; evaluate the distribution characteristics and correlations of physiological and pathological positive uptake, and using pathological results as the gold standard, assess the diagnostic efficacy of 68Ga-NOTA-RCCB6 PET/CT in renal cell carcinoma.
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Sequential
68Ga-NOTA-RCCB6 PET/CT Scan
Diagnostic testThe imaging agent 68Ga-NOTA-RCCB6 used in this project is synthesized following the standards for radiopharmaceutical production, with reference to the Chinese Pharmacopoeia (quality standards for 18F-FDG). The pH value is between 5.0 and 8.0; the radiochemical purity is not less than 95%, and the bacterial endotoxin content in each milliliter of solution is less than 15EU; the radioactive concentration is not less than 37 MBq/mL; the solvent residues comply with the regulations. Specification: 185\~1850 MBq/ml Characteristics: Clear, colorless, no visible particles. Radioactive physical half-life: 68Ga is 68 minutes. Expiry: Calculated from the time of labeling, stable for 3 half-lives. Administration method: Intravenous injection. Dosage: 0.05-0.1mCi/kg, flush with 5 mL of saline after injection. The maximum mass dose of CD70 should not exceed 240ug, and the maximum volume of administration should not exceed 5 mL.
Maximum Standardized uptake value (SUVmax)
Maximum Standardized uptake value (SUVmax) of \[68Ga\]RCCB6 and \[68Ga\]PSMA in the included subjects' primary and/or metastatic lesions.
Mean Standardized Uptake Value(SUVmean) of liver
Mean Standardized uptake value (SUVmean) of \[68Ga\]RCCB6 and \[68Ga\]PSMA in the included subjects' liver.
Tumor to Background Ratio(TBR)
TBR=SUVmax/SUVmean
The correlation between CD70 expression and [18F]RCCB6 uptake value
The Standardized uptake value (SUV) of \[68Ga\]RCCB6 will be calculated, and the correlation between pathological results and tumor uptake of \[68Ga\]RCCB6 will be analyzed.
Diagnostic value of 68Ga-NOTA-RCCB6 PET/CT in patients with RCC
We will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of 68Ga-NOTA-RCCB6 PET/CT in patients with RCC. We will also compare the diagnostic value of \[68Ga\]RCCB6 with \[68Ga\]PSMA. All the above goals will be achieved by analyzing the 68Ga-NOTA-RCCB6 PET/CT and 68Ga-PSMA PET/CT imaging data.
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