Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)

Study Overview
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Brief Summary
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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.

Official Title
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Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)

Conditions
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Renal Cell Carcinoma (RCC)

Intervention / Treatment
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* Procedure: Trans-arterial embolization (TAE)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RCC Participants<br>Receive Trans-arterial embolization (TAE) | Procedure: Trans-arterial embolization (TAE)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |