Use of 68Ga-NYM096 PETCT to Detect Clear Cell Renal Cell Carcinoma in Patients With Complex Renal Cysts Scheduled for Surgery A Phase 2 Diagnostic Study

What this Trial Is About

Researchers are evaluating the diagnostic accuracy of 68Ga-NYM096 PETCT for detecting clear cell renal cell carcinoma ccRCC in patients with complex renal cysts scheduled for surgical removal. This phase 2, single-center, single-arm study aims to compare PETCT results with histopathological diagnosis to assess sensitivity and specificity. The goal is to determine how well 68Ga-NYM096 PETCT can identify ccRCC non-invasively before surgery. Each participant will receive a single intravenous dose of 68Ga-NYM096, followed by whole-body PETCT imaging about 45 to 75 minutes after injection. Before surgery, contrast-enhanced CT scans of the abdomen and chest if indicated will be performed. PETCT and CT images will be evaluated independently by blinded readers, and results will be compared with tissue analysis after kidney resection. The study will also explore PETCTs ability to detect metastases compared to CT. Participants will undergo PETCT and CT imaging prior to kidney surgery. The pathologist will analyze tumor tissue for histology, grading, and CAIX expression. Researchers will assess diagnostic accuracy measures such as sensitivity, specificity, and predictive values within one month after study completion. The study involves 39 patients and follows ethical and regulatory standards. Participation includes imaging, surgery, and histological testing over the study period ending in 2027.

68Ga-NYM096 PET/ CT for the Detection of ccRCC in Presurgical Patients With Complex Cystic Renal Leision