Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)
Multi-center, single arm, prospective trial to estimate safety, feasibility, technical outcomes, and clinical outcomes of percutaneous cryoablation with neo-adjuvant trans-arterial embolization of the tumor in patients with T1b renal cell carcinoma. Continuous safety monitoring will be performed with stopping rules for patient accrual or study continuation.
• Aged ≥18 years
• Solid renal mass consistent with RCC on either ultrasound, MRI, or CT
• Longest tumor diameter measures 4.1-7cm
• Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study