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

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.

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Key information

Conditions

Renal Cell Carcinoma (RCC) Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged ≥18 years
Solid renal mass consistent with RCC on either ultrasound, MRI, or CT
Longest tumor diameter measures 4.1-7cm
Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion criteria

Pregnancy
Severe renal insufficiency with an Estimated Glomerular Filtration Rate (eGFR) <30
Renal cell carcinoma as part of a syndrome
Horseshoe kidney
Patient unable to undergo renal mass protocol CT or MRI
Severe allergy to iodinated contrast not mitigated by steroid and diphenhydramine prophylaxis
Uncorrectable coagulopathy, including a platelet count of <30,000/μL and/or an international normalized ratio (INR) >2.5 that does not respond to platelet transfusion or prothrombin complex concentrate infusion, respectively
Performance status precludes enrollment as determined by the investigators

Treatment and study plan

Trans-arterial embolization (TAE)

Procedure

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

Varian, a Siemens Healthineers Company

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jun 8, 2022
Registry last updated: Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed