Embolization before treating kidney cancer

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

This study is testing if blocking blood flow to kidney tumors with a procedure called embolization before freezing them with cryoablation can be safe and effective for people with early-stage kidney cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Locations: 4 sites (Birmingham, Alabama and 3 other locations)
• Trial ID: NCT05410509 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and feasibility of using trans-arterial embolization (TAE) followed by percutaneous cryoablation in patients with T1b renal cell carcinoma. It is a multi-center, single-arm, prospective trial that aims to assess technical outcomes and clinical results while continuously monitoring safety. Participants will undergo TAE to reduce blood flow to the tumor before the cryoablation procedure. The study will include strict eligibility criteria to ensure patient safety and compliance.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a solid renal mass measuring 4.1-7cm, classified as T1bN0M0 without vascular invasion or metastasis.

Not a fit: Patients with severe renal insufficiency, pregnancy, or those with certain anatomical or medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with renal cell carcinoma by enhancing the effectiveness of tumor ablation.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in combining embolization with ablation techniques for cancer treatment.

Eligibility criteria

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

Where this trial is running

Birmingham, Alabama and 3 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
• Stanford Cancer Institute — Stanford, California, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• Thomas Jefferson Health — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Andrew Gunn, MD — University of Alabama at Birmingham
• Study coordinator: Evan Hudson, MS

Conditions Renal Cell Carcinoma