68Ga-NYM096 PET/ CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Complex Cystic Renal Leision
This is a prospective, single-center, single-arm, diagnostic phase 2 study aimed at evaluating the sensitivity and specificity of 68Ga-NYM096 PET/CT in detecting clear cell renal cell carcinoma (ccRCC) in patients with complex renal cysts who are scheduled for surgical resection. The study will use histopathological diagnosis as the reference standard to assess the diagnostic accuracy of 68Ga-NYM096 PET/CT in identifying ccRCC within operable complex renal cystic lesion. The findings will provide critical insights into the performance of 68Ga-NYM096 PET/CT as a non-invasive imaging tool for the preoperative detection of ccRCC in this patient population.
• Age ≥ 18 y
• Presence of complex renal cyst (Bosniak category II or higher)
• Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique)
• Expected survival of at least 3 months
• ECOG ≤ 2
• Written informed consent provided for participation in the trial
• In the opinion of investigator, willing and able to comply with required study procedures.