"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.

Study Overview

• Status: Completed
• Conditions: Renal Cell Carcinoma (RCC)
• Intervention / Treatment: Procedure: Trans-arterial embolization (TAE)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Stanford, California, United States, 94305
      • Stanford Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged ≥18 years
2. Solid renal mass consistent with RCC on either ultrasound, MRI, or CT
3. Longest tumor diameter measures 4.1-7cm
4. Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease
5. 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
6. Provision of signed and dated informed consent form
7. Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

1. Pregnancy
2. Severe renal insufficiency with an Estimated Glomerular Filtration Rate (eGFR) <30
3. Renal cell carcinoma as part of a syndrome
4. Horseshoe kidney
5. Patient unable to undergo renal mass protocol CT or MRI
6. Severe allergy to iodinated contrast not mitigated by steroid and diphenhydramine prophylaxis
7. 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
8. Performance status precludes enrollment as determined by the investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: RCC Participants; Receive Trans-arterial embolization (TAE)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of patients experiencing major adverse events defined as anything grade C or above by Society of Interventional Radiology Guidelines.	30-90days post procedure

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Varian, a Siemens Healthineers Company
• Investigators: Principal Investigator: Andrew Gunn, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2024
• Primary Completion (Actual): November 19, 2025
• Study Completion (Actual): November 19, 2025

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: IRB-300009465 EMBARC; 000536794 (Other Grant/Funding Number: Varian Medical Systems)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No