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Evaluating the effects of complete tumor histotripsy ablation and immunostimulation in canine osteosarcoma

Purpose

To evaluate the effects of histotripsy, a treatment for that can destroy tissue without radiation or heat, in combination with an immunostimulatory drug, on dogs with osteosarcoma.

Background

In this study, we’re evaluating histotripsy, a new, non-invasive way of treating canine osteosarcoma (OS), on dogs whose owners have decided not to pursue standard cancer treatments like limb amputation surgery, chemotherapy, or radiation. 

Osteosarcoma is the most common primary bone tumor in dogs, and it primarily affects large and giant-breed dogs. Histotripsy has the potential to destroy OS tumors non-invasively and help dogs with OS preserve their limbs. It may also offer some relief from tumor-related pain.

Histotripsy delivers precise, non-thermal focused ultrasound waves that mechanically break apart tumors. In our previous research, we’ve learned that dogs can be safely treated with histotripsy and that histotripsy treatment seems to stimulate the immune system in ways that may help the body fight cancer. In this study, we want to add a new drug to the histotripsy treatment protocol. We hope that, combined with histotripsy, it will stimulate the immune system even more. We also want to evaluate the use of urine samples as a liquid biopsy tool to monitor disease progression in these dogs.

Eligibility

  • Confirmed diagnosis or probable diagnosis of appendicular osteosarcoma. If OS is suspected via radiographs (x-rays) or other imaging, please contact us.  Cytology/histopathology are not required for referral.
  • Owners have declined standard-of-care treatment for OS (surgical tumor removal or radiation therapy or chemotherapy)
  • Appropriate tumor volume based on radiographic measurements by the clinical trial team 
  • Absence of radiographic subchondral bone lysis of affected bone, as determined by the clinical trial team  

Exclusion

  • Presence of other life-threatening diseases
  • Previous local or systemic anti-cancer treatments (radiation therapy, chemotherapy, surgical tumor resection)

Study Design

To enroll in this study, dogs must have been diagnosed with osteosarcoma based on imaging (e.g. x-rays) and other clinical findings, or by analyzing a sample of the tumor. Dogs whose owners have decided not to pursue standard cancer treatments like amputation surgery, chemotherapy, or radiation, will be enrolled.

Once enrolled, dogs with osteosarcoma will undergo MRI scans and histotripsy treatment of the tumor. Histotripsy is a non-invasive treatment that is delivered through the skin using ultrasound waves. Most patients recover uneventfully and go home the same day. Depending on the size and location of the tumor, more than one treatment may be required.

Immediately after the last histotripsy treatment, while the patient is still anesthetized, patients will receive a single injection of an experimental compound called N-dihydrogalactochitosan (GC). This compound is designed to boost the body’s immune system to help it better recognize and fight cancer.

Your dog will stay in the study for the rest of his or her life, unless you decide to stop your participation. You may withdraw your dog from the study at any time if you elect to pursue other cancer treatments.

After your dog dies, whether from euthanasia or other causes, we would like to examine the affected limb to learn more about how the treatment worked. We will work with you and your local veterinarian to facilitate this postmortem examination. We ask that you contact us in advance if you plan to euthanize your dog, so we can make appropriate arrangements. This postmortem data collection is important to the study, and we appreciate your willingness to facilitate this to the best of your ability.

Urine sample collection and chest x-rays will be taken during routine clinical visits, at the following time points:

  • Prior to histotripsy and immediately following histotripsy treatment (while the dog is in the hospital)
  • 2, 4, 8 and 12 weeks after histotripsy treatment
  • As needed, if the dog’s clinical condition changes.

Compensation

The study covers the cost of urine sampling and chest x-rays needed for the study. The study also covers the costs of histotripsy treatment, including the MRIs for the study and hospitalization.

The study does not cover costs associated with any complications from study procedures such as urine collection. The costs associated with other standard diagnostics and care for canine osteosarcoma patients that are not part of this study are the responsibility of the owner.

Contact

  • If you'd like to proceed with a study screening appointment, please ask your veterinarian to initiate a referral using this link: https://cancercare.vetmed.vt.edu/appointments-and-referrals.html. Please note that the cost of the screening visit is typically not covered by the study.
  • If you'd like to be contacted with more information about this study and/or would like to discuss a case prior to referral, please complete our phone consultation request form: https://virginiatech.questionpro.com/t/AUEYyZu6hU.
  • If your query is urgent, please call the Animal Cancer Care and Research Center on 540-526-2300.

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