Print

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

  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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Evan Hudson
205-934-6499
evanhudson@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

April Riddle, BS
205-934-6504
ariddle@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.