RecruitingNot ApplicableNCT05410509

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

Sponsor

University of Alabama at Birmingham

Enrollment

25 participants

Start Date

Jan 3, 2024

Study Type

INTERVENTIONAL

Conditions

Renal Cell Carcinoma (RCC)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria8

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

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.