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.

Stanford Investigator(s):

Nishita Kothary, MD

Intervention(s):

procedure: Trans-arterial embolization (TAE)

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

Ages Eligible for Study

18 Years and older

Genders Eligible for Study

All