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Patient-derived organoids to develop high-frequency irreversible electroporation (H-FIRE) for treating metastatic lung tumors secondary to osteosarcoma: a pilot study

Purpose

To obtain information on the effects of H-FIRE, a therapy that can destroy tissue without radiation or heat, on dogs with metastatic osteosarcoma.

Background

Osteosarcoma is the most common primary bone tumor in dogs. It primarily affects large and giant-breed dogs, but can affect dogs of any breed and age. The cancer frequently metastasizes to the lungs. New treatment options are needed for osteosarcoma, because patient survival times have improved little over the past several decades.

High Frequency Irreversible Electroporation (H-FIRE) is a novel non-thermal technique that can precisely destroy tumors while sparing critical structures. H-FIRE also potentially induces an anti-tumor immune response, which may help to guard against further metastatic disease development.

This study proposes to evaluate the feasibility and safety of treating canine metastatic osteosarcoma lung tumors with H-FIRE, and to learn more about the effects of H-FIRE on patients with metastatic osteosarcoma. Because canine osteosarcoma is similar to human osteosarcoma, this work may inform future studies to evaluate the use of H-FIRE in people. 

Eligibility

  • Dogs of any age, weight, sex, or breed with a cytological or histological diagnosis of metastatic lung tumor(s)
  • Dogs must have a radiographic or CT diagnosis of more than 1 pulmonary metastatic tumor, with at least 1 of these tumors measuring no greater than a diameter of 3 cm
  • Tumor(s) must be determined to be accessible for H-FIRE treatment
  • Owners have declined to have the metastatic lung tumor(s) surgically removed and declined rescue chemotherapy for their dog
  • Dogs have not received any tumor-directed therapy against metastatic OS or immunomodulatory drugs within 1 month prior to study enrollment.
  • Dogs must be free from other significant systemic illness.

Exclusion

  • Dogs who have received any tumor-directed therapy (e.g. radiation), immunotherapy, or immunosuppressive drugs within 1 month prior to study enrollment.
  • Patients who are clinically ill from their metastatic tumors and have a life expectancy of under 2 weeks 

Study Design

Once enrolled, dogs with metastatic osteosarcoma will undergo CT scans and H-FIRE treatment of a metastatic tumor. Dogs undergo recheck CT scans at three timepoints: 7, 30 and 60 days, and peripheral blood sampling at four timepoints: 7, 14, 30, 60 days after H-FIRE treatment.

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 collect the metastatic tumor samples 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 H-FIRE, imaging, and recheck examination costs will be covered by the study. If your dog experiences any side effects from the H-FIRE treatment and/or from your decision not to pursue surgery, chemotherapy or radiation, those costs will be your financial responsibility.

Contact

  • Dr. Joanne Tuohy, Surgical Oncology
    Clinic Phone: (540) 526-2300
  •  Mindy Quigley, Clinical Trials Coordinator
    Office Phone: (540) 231-1363 | Email: mindyq@vt.edu  

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