CClinicalTrials.gg
CompletedNCT05410509Updated Jun 29, 2026

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

An interventional study of Trans-arterial embolization (TAE) in Renal Cell Carcinoma (RCC), sponsored by University of Alabama at Birmingham. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Cell Carcinoma (RCC)
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In context

Carcinoma, Renal Cell

1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.

This study's enrollment of 25 is below the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    RCC Participants

    Receive Trans-arterial embolization (TAE)

    Procedure: Trans-arterial embolization (TAE)

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.

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What researchers measure

Primary outcomes

  1. 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

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05410509
Lead sponsor
University of Alabama at Birmingham
Collaborators
Varian, a Siemens Healthineers Company
Responsible party
Andrew J. Gunn (Associate Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Jun 8, 2022
Start date
Jan 3, 2024
Primary completion
Nov 19, 2025
Completion
Nov 19, 2025
Last update
Jun 29, 2026

Study contacts

Andrew Gunn, MD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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