What side effects are associated with this type of intervention?

Percutaneous cryoablation and trans-arterial embolization are common treatments for kidney cancer. Cryoablation, which destroys cancer cells by freezing, can lead to side effects such as bleeding, infection, damage to surrounding tissues, and in rare cases, acute obstructive renal failure due to blood clots. Trans-arterial embolization, which blocks the blood supply to the tumor, may cause post-embolization syndrome characterized by pain, fever, nausea, and fatigue. Both treatments are generally well-tolerated but require careful monitoring for potential complications.

What prior FDA approvals exist?

The FDA has approved several treatments for kidney cancer, including minimally invasive techniques like cryoablation and embolization. Cryoablation, which destroys cancer cells by freezing, and trans-arterial embolization, which blocks the blood supply to the tumor, are similar to the treatments being studied in the trial. Additionally, systemic therapies such as immunotherapy with checkpoint inhibitors (e.g., nivolumab, pembrolizumab) and targeted therapies (e.g., sunitinib, axitinib) have also been approved for advanced renal cell carcinoma. These treatments offer various options for managing kidney cancer, particularly in cases where surgery is not feasible.

What other types of research exist?

Promising novel alternatives for kidney cancer treatment in 2024 include: 1) Immunotherapy agents such as Pembrolizumab and Atezolizumab, which are being evaluated in clinical trials for their efficacy post-nephrectomy. 2) Stereotactic Body Radiotherapy (SBRT), which is useful for treating a limited number of metastases and has shown potential in oligometastatic renal cell carcinoma. 3) Adjuvant therapies like Pembrolizumab, which have shown promise in improving disease-free survival in high-risk patients post-surgery. These alternatives offer different mechanisms of action and may provide additional options for patients depending on their specific clinical scenario.

← Back to Search

Embolization Before Ablation for Kidney Cancer

N/A

Recruiting

Led By Andrew Gunn, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged ≥18 years

Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease

Must not have

Renal cell carcinoma as part of a syndrome

Horseshoe kidney

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from TAE might include pain at the injection site, fever, nausea or vomiting. Cryoablation could cause bleeding around the kidney, damage to nearby organs or tissues and infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

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

Select...

My kidney tumor is confirmed by imaging tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney cancer is part of a genetic condition.

Select...

I have a horseshoe kidney.

Select...

I cannot have a CT or MRI for my kidney condition.

Select...

My blood does not clot properly, and treatments have not worked.

Select...

My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RCC ParticipantsExperimental Treatment1 Intervention

Receive Trans-arterial embolization (TAE)

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cryoablation destroys kidney cancer cells by freezing them, causing ice crystals to form inside the cells, leading to cell death. This minimally invasive technique preserves more kidney function compared to traditional surgery. Trans-arterial embolization blocks the blood supply to the tumor, starving the cancer cells of oxygen and nutrients, which leads to their death and can reduce tumor size. These treatments are crucial for kidney cancer patients as they offer effective, nephron-sparing options that maintain kidney function while targeting the tumor.

Current status of cryotherapy for prostate and kidney cancer.