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

Not Applicable

Recruiting

• Conditions: Renal Cell Carcinoma (RCC)
• Interventions: Procedure: Trans-arterial embolization (TAE)

• Registration Number: NCT05410509
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-08
• Study Start: 2024-01-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RCC Participants	Trans-arterial embolization (TAE)	Receive Trans-arterial embolization (TAE)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Stanford Cancer Institute; 🇺🇸 Stanford, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Thomas Jefferson Health; 🇺🇸 Philadelphia, Pennsylvania, United States