Overview
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnancy
- Severe renal insufficiency with an Estimated Glomerular Filtration Rate (eGFR) <30
- Renal cell carcinoma as part of a syndrome
- Horseshoe kidney
- Patient unable to undergo renal mass protocol CT or MRI
- Severe allergy to iodinated contrast not mitigated by steroid and diphenhydramine prophylaxis
- Uncorrectable coagulopathy, including a platelet count of <30,000/μL and/or an international normalized ratio (INR) >2.5 that does not respond to platelet transfusion or prothrombin complex concentrate infusion, respectively
- Performance status precludes enrollment as determined by the investigators