RecruitingNot ApplicableNCT05410509

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

Sponsor

University of Alabama at Birmingham

Enrollment

25 participants

Start Date

Jan 3, 2024

Study Type

INTERVENTIONAL

Conditions

Renal Cell Carcinoma (RCC)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether doing an embolization procedure (blocking the tumor's blood supply) before ablation (using heat or cold to destroy the tumor) improves outcomes for people with kidney cancer (renal cell carcinoma) that is medium-sized and confined to the kidney. **You may be eligible if...** - You are 18 or older - You have a solid kidney mass consistent with renal cell carcinoma on imaging - Your tumor measures between 4.1 and 7 cm - The tumor has not spread to lymph nodes or other organs (T1b stage) - You are willing to use contraception if you are of childbearing potential **You may NOT be eligible if...** - Your tumor is smaller than 4.1 cm or larger than 7 cm - The cancer has spread beyond the kidney - You have specific conditions that make the procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETrans-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.