Use of AI-enhanced patient-specific biomechanical modeling to identify dogs with appendicular osteosarcoma undergoing stereotactic body radiation therapy who would benefit from minimally-invasive intramedullary stabilization
The aim of this study is to perform initial testing for stabilization of long bones affected by osteosarcoma using a minimally-invasive implant with FDA approval for use in humans. A previous study performed by the OSU-VMC determined that this implant was safe and well-tolerated in dogs. The current study uses artificial-intelligence (AI)-enhanced, patient-specific biomechanical modeling to identify dogs at higher risk of experiencing a fracture from their tumor and determines whether they would benefit from receiving the implant. Ultimately, the idea is that this minimally-invasive technology could be used to prevent pathologic fractures for dogs who undergo stereotactic body radiation therapy for osteosarcoma.
Each dog will receive a CT scan for radiation therapy planning, followed by 3 treatments of radiation therapy to the tumor. The CT scan will also be used to assess the risk of fracture and determine whether the dog would benefit from placement of the implant. If determined that the dog’s fracture risk would be improved by placement of the implant, following completion of radiation therapy, the dog will be placed under general anesthesia the day after the final radiation therapy treatment for implantation of the device. Dogs enrolled in this trial will undergo chemotherapy treatment with carboplatin, an intravenous chemotherapy, for up to 6 treatments following completion of stereotactic body radiation therapy.
Gait analysis will be performed at enrollment and at the 2 week recheck examination, followed by every 2 months, along with chest x-rays to monitor for spread of disease.
Client Compensation:
The costs of the following will be covered as part of the study: pre-operative limb CT, pre-operative initial gait evaluation, anesthesia for implant placement, implant and implant application, intra-operative fluoroscopy, histopathology, and post-operative limb radiographs. The study will also cover the cost of follow-up limb radiographs and gait evaluations. In addition, at the conclusion of participation in the study, you will be provided with a $1000 direct payment to help cover other costs associated with treatment of the osteosarcoma. This study does not cover the cost of stereotactic body radiation therapy or chemotherapy.
Potential Medical Benefits:
Dogs participating in this study may avoid developing pathologic fractures of the limb affected with osteosarcoma. The goal is to determine whether the AI-enhanced modeling and application of the implant to patients at risk of fracturing can prevent the development of fractures.
Potential Medical Risks:
There are some risks associated with anesthesia and surgery that will be explained by the primary clinician and detailed on the consent form for the procedure. There are some risks associated with radiation therapy that will be explained by the primary clinician. The risks associated with the implant include implant failure, infection, pathologic fracture, and tumor recurrence. It is possible that dogs in this study may experience unexpected side effects resulting from anesthesia or surgery. It is possible that the dog’s condition may not improve or may worsen. The dogs will be observed closely for side effects and appropriate medical care will be provided.
Diagnosis/Condition Being Studied: Osteosarcoma of the limb
Intervention to Be Studied: Minimally-invasive intramedullary implant following SBRT
What qualifies my pet for enrollment?
Inclusion Criteria:
• Radiographic suspicion for or cytologic/histopathologic diagnosis of osteosarcoma in the appendicular skeleton (limb)
• Intention to treat with stereotactic body radiation therapy (SBRT)
• Intention to treat with chemotherapy
Exclusion Criteria:
• Lack of cytologic diagnosis or radiographic suspicion for osteosarcoma
• Osteosarcoma not located within a limb
• Evidence of lung metastasis on chest x-rays
• Evidence of pathologic fracture at initial assessment
PRE-SCREENING QUESTIONNAIRE
If you believe your pet may be eligible for this trial, please complete a pre-screening questionnaire.