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

NCT05410509 | Completed DMC

• 2 other identifiers: EMBARC000536794
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief 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)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

RCC Participants

EXPERIMENTAL

Receive Trans-arterial embolization (TAE)

Procedure: Trans-arterial embolization (TAE)

Interventions

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.

RCC Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Varian, a Siemens Healthineers Company: collaborator

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Stanford Cancer Institute

Stanford, California, 94305, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Thomas Jefferson Health

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Andrew Gunn, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 8, 2022
• Study Start: January 3, 2024
• Primary Completion: November 19, 2025
• Study Completion: November 19, 2025
• Last Updated: April 14, 2026

Record last verified: 2025-12

Locations

US (4)