Study of Radiation Therapy Guided by 68Ga-NY104 and 18F-FDG PETCT Combined with Systemic Treatment for Patients with Clear Cell Renal Cell Carcinoma

What this Trial Is About

Researchers are evaluating the combination of 68Ga-NY104 and 18F-FDG PETCT guided radiation therapy with standard systemic treatment in patients who have metastatic clear cell renal cell carcinoma ccRCC. This phase 2 study focuses on improving treatment outcomes by targeting metastatic lesions more precisely using advanced imaging techniques. The biomarker CAIX, targeted by 68Ga-NY104, has shown promise in detecting ccRCC lesions effectively. Participants will receive radiation therapy planned to cover as many metastatic lesions as possible, guided by baseline PETCT scans using both 68Ga-NY104 and 18F-FDG. Systemic therapy, which may include targeted therapy, immunotherapy, or both, will be given concurrently and determined by the treating urology oncologist. Follow-up 68Ga-NY104 PETCT scans will be done at 6, 12, and 24 months if the tumor is controlled, with additional scans as needed for suspected recurrence. During the study, patients will undergo multiple PETCT scans and other imaging to assess lesion uptake and detection. Researchers will monitor progression-free survival, disease control, overall survival, and adverse events over four years after treatment starts. The study tracks tumor response and safety outcomes while patients continue systemic therapy, with active follow-up for disease status and imaging assessments throughout the trial period.

68Ga-NY104 PET/CT Guided Radiation Therapy in CcRCC.