Pilot Study of Lipoma Reduction Using Focused Cold Therapy
- Soft Tissue Surgery
The purpose of this clinical trial is to evaluate a new approach to treat lipomas in dogs. A lipoma is a benign tumor of fat that is quite common in dogs, especially as they age. Dogs are also likely to develop multiple lipomas over the body. While in most cases lipomas do not pose a risk to dogs, they can become quite large and occasionally impact leg movement (gait) if they are next to or behind a leg or other quality-of-life activities such as pain or discomfort lying on one side. Also, some dogs have so many lipomas they can be hard to track, and as a result, a more serious tumor can be missed. At the moment, the only way to treat a lipoma is to remove it surgically, which requires general anesthesia. Because lipomas commonly occur in older dogs, the risk associated with anesthesia may be higher; therefore, surgical removal is often not recommended. The purpose of the following trial is to evaluate a new, nonsurgical approach to eliminate lipomas using focused cold therapy. The mechanism of cold therapy is not new, as “cold sculpting” based treatments are FDA approved for use in people to eliminate areas of fat on the body. In this canine trial, the effects of a single injection of a new cold medium into a lipoma will be evaluated. The focused cold therapy contains no drugs and acts to freeze fat cells in the lipoma from the inside out, and hopefully causes their natural destruction, re-absorption, and therefore shrinking of the lipoma.
- Diagnosed with two cytologically confirmed lipomas that are at least 2 cm and no larger than 7cm in size
- At least 1 year of age and weigh at least 5 kg (11 pounds)
- Adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis)
- Otherwise medically healthy with no clinically significant physical findings upon examination, medical history and clinical laboratory profile, as deemed by the principal investigators (PIs)
- Estimated life expectancy of at least 2 months
- Owner informed written consent
- Pregnant or lactating dogs
- Significant liver, renal or cardiovascular disease
- Any serious systemic disorder incompatible with the study
- Use of any other investigational drug within 2 weeks of study entry
- The benefit to your dog is that he/she will have both studied lipomas removed at the end of the study.
- It is also possible that during the study, at least one of the lipomas will shrink in size.
- Your dog will undergo lab-based blood evaluation; though not all routine measures may be assessed, any noteworthy findings will be reported to you
- All costs associated with this study including office visits, blood work, injections and surgical removal of the lipomas will be covered, including any complications (i.e., infection) should they occur. The study will NOT cover any non-study related conditions such as ear infection, bladder infection, removal of other tumors, etc.
Sample or Data Requirements
- Your dog will undergo a few tests to make sure that he/she is a good candidate for the study, including confirmation that at least two lipomas are present and of the appropriate size for injection, and that all blood work is normal. On the first study day, your dog will be sedated (not anesthetized), and two lipomas will be chosen for injection. One lipoma will be injected with saline (placebo) and the other with the cold medium. This cold medium has been tested in mice and pigs and was found to be safe. Following the injections, your dog’s sedation will be reversed and then observed for 1 hour. In general, the cold medium has its effect and then is absorbed within that same time period. Your dog will then go home and later will return for a series of recheck exams to measure both the placebo and cold medium injected lipomas to track their sizes at 2 weeks, 4 weeks and 8 weeks after injection. Lipoma size measurements will be performed both using calipers and ultrasound, neither of which require any sedation. At the 4 week visit, we will also repeat bloodwork. At the 8 week visit, after measurement, your dog will undergo general anesthesia and the lipomas will be removed for evaluation. Your dog will likely go home the same day as the surgery.
For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: firstname.lastname@example.org