Embolization Before Ablation for Kidney Cancer

Recruiting at 3 trial locations

Overseen By Evan Hudson, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pregnancy, Severe renal insufficiency, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of a new treatment approach for kidney cancer. The method, called trans-arterial embolization (TAE), blocks blood flow to the tumor before freezing it through cryoablation. The trial seeks participants with a kidney tumor measuring between 4.1 and 7 centimeters that has not spread to other parts of the body. Individuals with a solid kidney tumor confirmed by an ultrasound, MRI, or CT scan may be eligible to join. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new treatment options for kidney cancer.

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 prior data suggests that trans-arterial embolization is safe for kidney cancer patients?

Research has shown that trans-arterial embolization (TAE) is generally safe for treating kidney cancer. One study successfully performed TAE in 16 out of 17 patients, proving it safe and feasible. Another study found that TAE worked well with few complications, indicating that serious side effects were rare. While some studies have examined TAE combined with other treatments, TAE alone still demonstrated a strong safety record. Overall, TAE is well-tolerated, with few patients experiencing major problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Trans-arterial embolization (TAE) is unique because it offers a targeted approach to treating kidney cancer by cutting off the blood supply to the tumor, which can shrink or kill it. Unlike traditional treatments like surgery or systemic therapies that affect the whole body, TAE focuses directly on the blood vessels feeding the cancer, potentially leading to fewer side effects. Researchers are excited about TAE because it has the potential to enhance the effectiveness of subsequent treatments like ablation, making it a promising addition to kidney cancer care.

What evidence suggests that trans-arterial embolization is effective for kidney cancer?

Research shows that trans-arterial embolization (TAE), which participants in this trial will receive, holds promise for treating kidney cancer. Studies have demonstrated TAE's success in nearly all patients, effectively targeting tumors. It reduces blood loss and eliminates the need for blood transfusions during the procedure. When used before cryoablation, a treatment that freezes the tumor to kill cancer cells, TAE enhances the treatment's effectiveness. Although more research is needed, these findings suggest that TAE can play a crucial role in managing kidney cancer by making tumors easier to treat and improving treatment outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Andrew Gunn, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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

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.

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Trans-arterial embolization (TAE)

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.

How Is the Trial Designed?

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+

Varian, a Siemens Healthineers Company

Industry Sponsor

Trials

35

Recruited

7,200+

Published Research Related to This Trial

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) 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]

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) 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6223823/

Transarterial embolization of renal cell carcinoma as an ... TAE was technically successful in 16 of 17 patients (unable to identify the tumor on angiography in one patient). PCA was technically successful in all patients ...

2. dirjournal.org dirjournal.org/articles/transarterial-embolization-of-renal-cell-carcinoma-as-an-adjunctive-therapy-prior-to-cryoablation-a-propensity-score-matching-analysis/dir.2018.18090

Transarterial embolization of renal cell carcinoma as an ... We aimed to assess the safety and effectiveness of transarterial embolization (TAE) prior to percutaneous cryoablation (PCA) in the management of renal cell ...

3. americanjir.com americanjir.com/transarterial-chemoembolization-for-renal-cell-carcinoma-patients-with-liver-metastases-in-the-era-of-immunotherapy-a-case-series/

Transarterial chemoembolization for renal cell carcinoma ... Transarterial chemoembolization (TACE) is a targeted regional treatment modality with evidence of efficacy in both primary and secondary ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2210261215003685

Case series Transarterial embolization of renal tumors ... Our review showed transarterial embolization had a decrease in blood loss and required no transfusions. It also facilitated a larger and more advanced tumor ...

5. nature.com nature.com/articles/s41598-022-12334-x

Transarterial chemoembolization of unresectable renal ... The median OS was 24.6 months, and the 3-, 6- and 12- month OS rates were 93.9%, 87.6% and 65.2%, respectively. There were no treatment-related ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30373723/

Transarterial embolization of renal cell carcinoma as an ... TAE of RCC prior to PCA is safe and technically feasible; however, no objective benefits over PCA alone were identified by propensity score matching ...

7. cvirendovasc.springeropen.com cvirendovasc.springeropen.com/articles/10.1186/s42155-024-00505-y

Clinical outcomes after emergency transarterial renal ... The present study reports high clinical success, low complications and low rebleeding rates of emergency renal TAE.

8. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-023-10754-0

Efficacy and safety analysis of TACE + sunitinib ... - BMC Cancer The aim of this study was to explore the efficacy and safety of TACE + sunitinib vs. sunitinib in the treatment of unresectable advanced RCC.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051044317307480

Transarterial Chemoembolization of Renal Cell Carcinoma Conclusions. DEE transarterial chemoembolization is safe for treating localized RCC and has a significantly superior cytoreductive effect compared with TAE.