"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged ≥18 years
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Solid renal mass consistent with RCC on either ultrasound, MRI, or CT
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Longest tumor diameter measures 4.1-7cm
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Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease
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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
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Provision of signed and dated informed consent form
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Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria:
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Pregnancy
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Severe renal insufficiency with an Estimated Glomerular Filtration Rate (eGFR) <30
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Renal cell carcinoma as part of a syndrome
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Horseshoe kidney
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Patient unable to undergo renal mass protocol CT or MRI
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Severe allergy to iodinated contrast not mitigated by steroid and diphenhydramine prophylaxis
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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
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Performance status precludes enrollment as determined by the investigators
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
Sponsors and Collaborators
- University of Alabama at Birmingham
- Varian, a Siemens Healthineers Company
Investigators
- Principal Investigator: Andrew Gunn, MD, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EMBARC