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"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"
Sponsor: University of Alabama at Birmingham
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2024-01-03
Completion Date
2027-12-31
Last Updated
2025-12-29
Healthy Volunteers
No
Conditions
Interventions
Trans-arterial embolization (TAE)
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.
Locations (4)
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