Canine Lipomas

Purpose

To evaluate the safety and effectiveness of treating lipomas in dogs with a single treatment.

Background

Lipomas are benign growths, representing the most common skin tumor in the dog.  Management of simple lipomas may only require observation.  However, larger or complex lipomas may need intervention, such as surgery with radiation in specific cases.  Histotripsy is a non-thermal focused ultrasound method that can precisely target and destroy abnormal tissues, without surgery or radiation.

Eligibility

• Eligibility will be determined by a physical exam and pre-screening bloodwork, xrays, and ultrasound.  
• Patients must be healthy enough for general anesthesia 
• The lipoma must be between 2-4 centimeters in diameter

Exclusion Criteria

• Patient's receiving chemotherapy or other immune suppressing treatments
• Patient's not healthy enough for general anesthesia
• Lipomas that do not fit the criteria of 2-4 centimeters in diameter 

Study Design

All owners will be told about the standard treatment options for lipomas, which include simply watching the lump over time or surgically removing it. If an owner chooses to join the study, their dog can participate as long as they meet certain requirements: the dog must have a confirmed lipoma, healthy kidney and liver function to handle anesthesia, no serious health conditions, and no recent immunotherapy or chemotherapy in the past six weeks. The owner must also give written consent.  Prior to treatment, each dog will have a physical exam, imaging tests, a cell analysis to confirm the lipoma, and a full blood test.

If the dog qualifies and the owner agrees to join the study, the dog will be scheduled for treatment. Owners will be given any important medical results from the trial.

Assignment to study groups

Each dog will be randomly placed into one of two treatment groups, using a method to ensure the groups are evenly balanced.

• Treatment Group 1: dogs will receive focused ultrasound histotripsy to break down the lipoma tissue, but the liquefied (destroyed) tissue will not be removed right away.
• Treatment Group 2: dogs will receive the same focused ultrasound histotripsy, but afterward, a small needle will be used to remove the liquefied tissue through the skin.

Following treatment there will be rechecks every 1 week for 4 weeks, and again at 6 weeks, 8 weeks, and 4 months.  

Compensation

Screening, treatment, and follow-up procedures described above will be covered by the project.

The costs of adverse events will not be covered. No compensation will be provided for additional treatments, diagnostic tests, or procedures outside of scope of the study.

Funded by

The Focused Ultrasound Foundation 

In Collaboration With

Therapeutic Ultrasound and Non-Invasive Therapies Laboratory