The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 68Ga-C1 in PET/CT imaging in clear cell renal cell carcinoma patients. It will also learn about the safety, tolerability and radiation dosimetry of 68Ga-C1. Researchers will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.
Carbonic anhydrase IX (CAIX) is a transmembrane protein which is highly expressed in approximately 95% of clear cell renal cell carcinomas, and it is closely related to tumor progression, patients prognosis and treatment response. Here, we developed a CAIX specific small molecule probe 68Ga-C1, which has shown a good diagnostic accuracy in PET/CT imaging in our preclinical mouse model of clear cell renal cell carcinoma. This enables high-contrast imaging of clear cell renal carcinoma, providing a new imaging method for the precise diagnosis of clear cell renal carcinoma. In this clinical trail, we will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
68Ga-C1 is injected intravenously with a dose of 0.05-0.10 mCi/kg
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of clear cell renal cell carcinoma
Compare the standardized Uptake Value (SUV) of lesions on 68Ga-C1 and 18F-FDG PET/CT
Time frame: 1 year
The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of malignant tumors
Compare the number of lesions detected by 68Ga-C1 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.
Time frame: 1 year
The dosimetry of 68Ga-C1
Research on the dose distribution of 68Ga-C1 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software
Time frame: 1 year
Quantitative evaluation of 68Ga-C1
Evaluation of quantitative parameters of 68Ga-C1, such as time-activity curve.
Time frame: 1 year
Correlation with pathological expression
Analyze CAIX expression at the imaging level in combination with CAIX expression in pathological specimens
Time frame: 1 year
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