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

Purpose

To evaluate the effects of histotripsy, a novel treatment for that can destroy tissue without radiation or heat, on dogs with osteosarcoma.

Background

In this study, we’re evaluating histotripsy, a new tumor ablation technique, as a non-invasive way of treating canine osteosarcoma (OS). Histotripsy delivers precise, non-thermal focused ultrasound waves that mechanically disintegrate tissues.

Osteosarcoma is the most common primary bone tumor in dogs, and it primarily affects large and giant-breed dogs. Limb amputation is commonly used to remove the tumor, but not all dogs are suitable for an amputation. Limb salvage surgery to preserve the limb and only remove the tumor has a high complication risk, and non-surgical options for limb preservation are extremely limited for canine OS. Histotripsy has the potential to destroy OS tumors non-invasively and help dogs with OS preserve their limbs.

In our previous research, we’ve delivered histotripsy prior to amputation surgery. Our results show that histotripsy is safe and feasible. However, we haven’t yet tested the effects of histotripsy for limb-sparing treatments (i.e. where the affected leg is not amputated after histotripsy treatment). The results of this study are critical to advancing the successful clinical implementation of histotripsy and contribute to our long-term goal of establishing histotripsy as a non-invasive limb salvage treatment for primary OS.

This study is funded by the Veterinary Memorial Fund.

Eligibility

  • Diagnosis of appendicular osteosarcoma confirmed by either cytology or histopathology. If OS is suspected via radiographs or other imaging, please contact us. We prefer to complete the screening diagnostics as part of the initial appointment. Cytology/histopathology are not required for referral.
  • Owners have declined standard-of-care treatment for OS (surgical tumor removal or radiation therapy)
  • 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 life-threatening comorbidities
  • Previous local or systemic antineoplastic treatments (radiation therapy, chemotherapy, surgical tumor resection)

Study Design

Once enrolled, dogs with appendicular osteosarcoma will undergo MRI scans and histotripsy treatment of the tumor at the Veterinary Teaching Hospital in Blacksburg, VA. Dogs will undergo examinations and owners will fill out electronic questionnaires regarding their dogs at the following time-points: 1, 7, 14, 30 days after histotripsy, and every 30 days thereafter.

Owners may elect for their dog to undergo chemotherapy following the histotripsy treatment. Chemotherapy is not provided as part of the study, and may be performed at a clinic of your choosing.

Your dog will stay in the study for the rest of his or her life, unless you decide to stop your participation. 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.

Compensation

There are no costs to you for your dog to participate in the study. All histotripsy, imaging and recheck examination costs will be covered by the study. If owners elect for their dog to undergo chemotherapy, the cost of chemotherapy treatment will be at their own expense. Owners who complete the study and submit their dog’s limb for postmortem examination will receive a modest cash payment.

Initial diagnostic examinations such as biopsy, fine needle aspirates, and limb x-rays are not covered by the study.

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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