Purpose and Brief Explanation of Study:
Osteosarcoma is the most common primary bone tumor in dogs. Limb amputation with adjuvant chemotherapy is the actual standard of care. Limb amputation is used as a palliative treatment: it allows us to remove the source of pain and to improve significantly the quality of life of our patients. Limb-sparing techniques can be used for dogs where amputation is prohibitive such as orthopedic or neurologic disease in other limbs, or owner request. Actual limb-sparing techniques (tumor removal and reconstruction of the bony column) are associated with very high complication rates: up to 96%, including infection, tumor regrowth, implant breakage or pathological fracture. Radiation therapy becomes more available and offers another alternative technique but up to 62% of the patients will develop a pathological fracture within 9 months after the initial treatment.
Microwave (MW) ablation, a new form of thermal ablation introduced in the 1990s, has emerged as a promising treatment option for numerous disease processes on the human side: direct treatment of primary hepatic, renal, pancreatic, prostatic or pulmonary tumors, and treatment of distant metastases (hepatic, pulmonary or bone metastases). Microwave ablation is a modality that achieves tumor destruction through heat, which is produced by the conduction of microwave energy. Recent technical improvements in MW devices and imaging modalities for placing antennas and monitoring energy delivery have helped establish MW as a viable and maturing treatment modality.
MW ablation has been recently used for the management of benign bone lesions and malignant bone lesions (mainly bone metastases) in people. Multiple studies revealed good results and significant improvement of these patients quality of life. Microwave ablation appeared to be a safe, and effective treatment of painful refractory bone and soft tissue tumors in people.
Objective of the trial:
The purposes of the study are to assess feasibility and safety of the microwave ablation therapy for the treatment of distal radial osteosarcomas in dogs, to measure the volume of treated tissue and to record the presence of collateral damages (soft tissue).
What qualifies my dog for enrollment in this in this trial?
To participate in this clinical trial your dog must have:
Dogs with a distal radial osseous lesion consistent with osteosarcoma (presentation, breed, age, radiographic findings, fine needle aspiration consistent with sarcoma) are eligible to enroll in this study.
What does enrolling my dog in this clinical trial involve?
Dogs enrolled in this study will receive MW ablation therapy of the distal radius 48 hours prior to limb amputation. Extension of the lesion will be assessed via a CT scan (allowing us to plan the ablation therapy). Then under general anesthesia, a microwave ablation probe will be inserted in the distal radius. Using a specific generator, defined areas of the bone (tumor) will be treated. Close monitoring will then follow: your dog will stay in ICU for 48 hours and treatments will be provided as needed. Forty-eight hours after the initial treatment, another CT scan will be performed to reassess the lesion followed by limb amputation.
Following your dog’s completion of the clinical trial, you will receive a credit of $2000 for continued treatment of your dog at the Veterinary Medical Center. The clinical trial will cover the costs associated with the ablation therapy including anesthesia, both CT (pre and post-operative), the ablation procedure, 48 hours of monitoring after the treatment and the potential complications associated with it.
If you believe your pet may be eligible to enter this study, please click here to fill out a questionnaire.
Dr. Vincent Wavreille, firstname.lastname@example.org