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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Trans-arterial embolization (TAE) is a minimally-invasive procedure in which the tumor-feeding arteries are catheterized under x-ray guidance and therapeutically occluded. TAE of the kidney is routinely performed in clinical practice for traumatic or iatrogenic injury or to de-vascularize tumors such as angiomyolipomas, oncocytomas, and RCC. The procedure has a long clinical history of success with a very low major complication rate. TAE of RCC with or without percutaneous cryoablation (PA) has been described in retrospective case series as a mechanism to destroy the tumor, reduce bleeding complications from PA, or improve symptoms of RCC such as pain or hematuria. However, these findings have yet to be confirmed in a rigorous, prospective fashion.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford Cancer Institute
Stanford, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Thomas Jefferson Health
Philadelphia, Pennsylvania, United States
The number of patients experiencing major adverse events defined as anything grade C or above by Society of Interventional Radiology Guidelines.
Time frame: 30-90days post procedure
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