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

Description

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)

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Renal Cell Carcinoma (RCC)
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Andrew Gunn, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2025-12-31