Renal Cell Carcinoma (RCC)
Conditions
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.
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.
Sponsors
University of Alabama at Birmingham
Varian, a Siemens Healthineers Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrew Gunn, MD
University of Alabama at Birmingham
Outcome results
None listed