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RECRUITING
NCT05410509
NA

"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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