Evaluating 68Ga-NOTA-RCCB6 PET/CT Imaging for Targeting CD70 in Renal Cell Carcinoma Diagnosis and Comparison with 68Ga-PSMA PET/CT

What this Trial Is About

Researchers are evaluating the use of 68Ga-NOTA-RCCB6 PET/CT imaging to detect and diagnose renal cell carcinoma (RCC), a type of kidney cancer. This prospective, open-label, single-center study includes 60 patients who have a high suspicion of RCC based on conventional imaging. The study aims to establish the best imaging protocol, understand how the imaging agent is distributed in the body, and assess how well this method identifies cancer compared to pathology results. Participants will receive an intravenous injection of 68Ga-NOTA-RCCB6 at a dose of 0.05-0.1 mCi/kg, followed by a PET/CT scan about 50 to 80 minutes after administration. The imaging agent meets strict quality standards, and the maximum amount of CD70 protein administered will not exceed 240 micrograms. The study includes several periods: a screening period up to 7 days before injection, the baseline day of injection and imaging, a safety monitoring period up to 4 days after injection, and a diagnostic follow-up period lasting up to 6 months to confirm imaging results with biopsy or surgery findings. During the study, patients will undergo medical history reviews, vital sign checks, and monitoring for any adverse reactions shortly after and up to 4 days post-injection. Researchers will collect imaging data, pathology results, and medication information throughout the study. The primary outcomes measured include standardized uptake values and tumor-to-background ratios from the PET/CT scans, as well as the correlation of these imaging results with CD70 expression. The total involvement for each participant can last up to six months to complete all follow-ups and analyses.

A Study Evaluating the Value of 68Ga-NOTA-RCCB6 PET Imaging for Targeting CD70 in the Clinical Staging, Therapeutic Evaluation, and Restaging of Renal Cell Carcinoma, and Comparing It with 68Ga-PSMA PET/CT Imaging