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

Renal Cell Carcinoma (RCC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05410509
• Other study ID #: EMBARC
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: University of Alabama at Birmingham
• Contact: April Riddle, BS
• Phone: 205-934-6504
• Email: ariddle[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma (RCC)

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Varian, a Siemens Healthineers Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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