[Translation] A confirmatory, open-label, single-arm, multicenter study to evaluate the safety, tolerability, and efficacy of 89Zr-labeled girentuximab (89Zr-TLX250) for the noninvasive detection of clear cell renal cell carcinoma (ccRCC) by PET/CT imaging in Chinese patients with indeterminate renal masses (ZIRCON-CP study)
主要目的:使用组织学作为真实标准,评估使用89Zr-TLX250 PET/CT成像定性评估在中国不确定性肾肿块(IRM)患者中无创检测ccRCC的敏感性和特异性
[Translation] Primary objective: To evaluate the sensitivity and specificity of 89Zr-TLX250 PET/CT imaging for the noninvasive detection of ccRCC in Chinese patients with indeterminate renal masses (IRMs) using histology as the true standard