High-Frequency Irreversible Electroporation (H-FIRE) for the treatment of primary or metastatic liver disease in dogs

Purpose

To determine if H-FIRE, which uses electrical pulses to destroy cancer cells, is a safe and effective ablative therapy for the treatment of primary, multi-focal, or metastatic liver cancer in dogs.

Background

There are currently limited options for the treatment of liver cancer in veterinary medicine. The prognosis for dogs diagnosed with non-resectable (inoperable) liver cancer has not improved over the past decades, with survival typically measured in weeks to months, despite chemotherapy, targeted therapies, and radiation therapy attempts. The response rates of solid tumors and associated liver metastases to conventional therapies are generally reported to be poor, with most studies failing to show significantly improved survival times.

A new technique with the ability to spare normal tissue and critical structures has the potential to translate into improved survival and quality of life. High Frequency Irreversible Electroporation (H-FIRE) is a non-thermal ablation technique using short, intense, electrical pulses to break down cancer cells. In this study, we’re testing if H-FIRE can be used to safely and effectively to treat primary or metastatic liver cancer.  

This study is funded by the Veterinary Memorial Fund.

Eligibility

• Diagnosis of primary, multi-focal, or oligometastatic liver cancer or nodular hepatocellular carcinoma (≤ 5 lesions)
• Expected survival ≥ 4 weeks without treatment
• Creatinine < 1.5x upper reference limit
• ALT, AST ≤ 4.0x upper reference limit
• Normal CBC or < Grade 2 VCOG cytopenias
• Modified Karnofsky Performance Score 0 or 1

Exclusion

• Presence of other life-limiting comorbidities
  
• Anti-neoplastic therapy for the past 3 weeks

Study Design

This study takes place at the Animal Cancer Care and Research Center (ACCRC) in Roanoke, VA.

A physical exam, chest and abdominal CT scan, needle biopsy of all target lesions, complete blood count, and serum biochemistry profile will be required for all dogs at screening. If all of the inclusion/exclusion criteria are met and the owner signs the informed consent, dogs will be scheduled for H-FIRE treatment at 10-14 days post CT. Between days 2-5 post H-FIRE treatment, we will repeat a CT of the liver. Scheduled recheck CT visits will take place 30 days post treatment, and then every 3 months until disease progression, at which time, ultrasound guided aspirate will be performed to confirm recurrence.

Please be aware that each patient represents a unique case that may require some variation on the treatment and follow-up plan. 

Compensation

The cost of screening visit and initial CT will be the responsibility of the owners, as it is part of the standard of care staging for solid tumors at the Animal Cancer Care Center. The approximate out-of-pocket cost for the owner is $2,500.

After initial screening, the study will cover the cost of follow-up CTs and bloodwork and provide up to $2,000 toward the cost of H-FIRE treatment. If an open surgical approach is elected, these funds will likely only partially cover the cost of the procedure. If a percutaneous approach is elected, these funds will likely cover the full cost of the procedure. If the disease has not progressed at the one-year time point (recheck 4), owners may choose to continue to monitor their dog’s condition at their own expense. 

Contact

Mindy Quigley, Clinical Trials Coordinator
Office Phone: 540-231-1363 | Email: vettrials@vt.edu

Dr. Nick Dervisis, Medical Oncology
Phone: 540-526-2300 | Email: dervisis@vt.edu

If your query is urgent, please call the Animal Cancer Care and Research Center on 540-526-2300.