Embolization Before Ablation for Kidney Cancer

Recruiting at3 trial locations

Overseen by Andrew Gunn, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pregnancy, Severe renal insufficiency, others

Stay on Your Current Meds

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment for kidney cancer that involves blocking the tumor's blood supply and then freezing it to kill the cancer cells. It targets patients with a specific type of kidney cancer that may not respond well to traditional treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Embolization Before Ablation for Kidney Cancer?

Research shows that trans-arterial embolization (TAE) is safe and technically feasible for treating kidney cancer, with successful outcomes in most patients and minimal complications. It has been effectively used in combination with other treatments like cryoablation, and similar techniques have shown effectiveness in other conditions like liver cancer. ^{1 2 3 4 5}

Is embolization before ablation for kidney cancer safe?

Research shows that embolization before ablation for kidney cancer is generally safe. In studies, the procedure was technically successful with no major complications reported, and only a few minor issues that did not need treatment. ^{1 2 3 4 6}

How does the treatment of embolization before ablation for kidney cancer differ from other treatments?

This treatment is unique because it combines trans-arterial embolization (blocking blood flow to the tumor) with ablation (destroying the tumor with extreme cold or heat), which may enhance the effectiveness of tumor destruction compared to ablation alone. It is particularly notable for its technical success and low complication rate, making it a safe and feasible option for patients with kidney cancer. ^{1 2 3 4 6}

Research Team

Andrew Gunn, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

The EMBARC trial is for adults with a specific kidney cancer (T1b renal cell carcinoma) that's between 4.1-7cm large, without spread or vascular invasion. Participants must be able to follow the study plan and use effective birth control if they can have children. People with severe kidney issues, part of a syndrome, certain anatomical abnormalities, poor performance status, contrast allergies not helped by meds, or serious blood clotting problems cannot join.

Inclusion Criteria

I am 18 years old or older.

The longest measurement of the tumor is between 4.1 and 7 centimeters.

My cancer is early stage, has not spread to lymph nodes or other parts of my body, and does not involve blood vessels.

Exclusion Criteria

You have a serious allergy to iodinated contrast that doesn't improve with steroid and diphenhydramine medication.

My kidney cancer is part of a genetic condition.

I have a horseshoe kidney.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive trans-arterial embolization followed by percutaneous cryoablation

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Trans-arterial embolization (TAE) (Procedure)

Trial Overview This study tests whether doing trans-arterial embolization (TAE) before freezing the tumor (cryoablation) is safe and works well for treating T1b renal cell carcinoma. It's done at multiple centers where everyone gets both treatments in a planned order to see how they do over time.

Participant Groups

Group I: RCC Participants Experimental Treatment 1 Intervention

Receive Trans-arterial embolization (TAE)

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Varian, a Siemens Healthineers Company

Industry Sponsor

Trials

35

Recruited

7,200+

Findings from Research

In a study of 155 transcatheter arterial embolization (TAE) procedures over 12 months, the use of TAE for palliative care has increased, showing its versatility in treating various renal conditions beyond just presurgical applications.

The technique remains highly effective with low morbidity, and the introduction of new embolization materials, such as ethanol and fine particles, has improved efficacy while reducing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current status of transcatheter arterial embolization in urology]. Resel Estévez, L., Mohamed, Z., Tobio, R.[2006]

Trans-arterial embolization (TAE) is being explored as a neoadjuvant therapy for renal cell carcinoma (RCC) to reduce tumor blood supply, which may help minimize blood loss during surgery and improve outcomes in patients undergoing percutaneous ablation.

While there are no definitive prospective trials proving TAE's benefits for RCC, retrospective studies suggest it may effectively alleviate symptoms like pain and hematuria, and emerging techniques like trans-arterial chemoembolization and radioembolization are being investigated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Angio-Embolization for Renal Cell Carcinoma. Gunn, AJ., Patel, AR., Rais-Bahrami, S.[2018]

Trans-arterial embolization (TAE) of renal cell carcinoma was performed successfully in 11 patients, with no complications reported, demonstrating its safety and technical feasibility as a pre-treatment before ablation.

Following TAE, 10 out of 11 patients underwent successful cryoablation or microwave ablation, with only 3 minor complications that did not require treatment and no adverse effects on kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans-Arterial Embolization of Renal Cell Carcinoma prior to Percutaneous Ablation: Technical Aspects, Institutional Experience, and Brief Review of the Literature. Gunn, AJ., Mullenbach, BJ., Poundstone, MM., et al.[2020]

In a study of 9 patients with stage 4 or 5 chronic kidney disease (CKD), cryoablation combined with transcatheter arterial embolization (TAE) effectively treated renal cell carcinoma (RCC) without local tumor progression during a median follow-up of 18 months.

The procedure was generally safe, with only one patient experiencing a significant complication, and the overall impact on renal function was acceptable, with a modest decrease in estimated glomerular filtration rate (eGFR) of 6.2 ml/min/1.73 m² in the remaining patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal cryoablation combined with prior transcatheter arterial embolization in non-dialysis patients with stage 4 or 5 chronic kidney disease: a retrospective study. Umakoshi, N., Iguchi, T., Matsui, Y., et al.[2023]

Transarterial embolization (TAE) effectively induces tumor necrosis in patients with advanced hepatocellular carcinoma (HCC), allowing some patients to meet the Milan criteria for liver transplantation after treatment.

In a study of 12 cirrhotic patients, TAE resulted in high survival rates of 92% at 1 year and 73% at 2 years post-transplant, demonstrating its potential to improve outcomes for patients awaiting liver transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The significance of transarterial embolization for advanced hepatocellular carcinoma in liver transplantation. Sun, PL., Chen, CL., Hsu, SL., et al.[2004]

Trans-arterial embolization (TAE) significantly improves symptoms like pain and hematuria in patients with renal cell carcinoma (RCC), with 98.3% of patients experiencing pain relief and 95% seeing improvement in hematuria after treatment.

While TAE shows promise in symptom management, its impact on oncologic outcomes like overall survival (OS) is less clear, with only one study demonstrating a significant improvement in OS compared to non-TAE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans-arterial embolization of renal cell carcinoma: a systematic review and meta-analysis. Wright, B., Johnson, BS., Vassar, M., et al.[2022]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Current status of transcatheter arterial embolization in urology]. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Role of Angio-Embolization for Renal Cell Carcinoma. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Trans-Arterial Embolization of Renal Cell Carcinoma prior to Percutaneous Ablation: Technical Aspects, Institutional Experience, and Brief Review of the Literature. [2020]

4. Japan pubmed.ncbi.nlm.nih.gov

Renal cryoablation combined with prior transcatheter arterial embolization in non-dialysis patients with stage 4 or 5 chronic kidney disease: a retrospective study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The significance of transarterial embolization for advanced hepatocellular carcinoma in liver transplantation. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Trans-arterial embolization of renal cell carcinoma: a systematic review and meta-analysis. [2022]