NCT05410509

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Cell Carcinoma (RCC)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-03
• Primary completion: 2025-11-19
• Completion: 2025-11-19
• First posted: 2022-06-08
• Last updated: 2026-04-14

Locations

4 sites across 1 country: United States