Cone-beam computed tomography guided percutaneous cryoablation of bone metastases treatment in patients with endocrine tumors.

• Grant number: 18/01656-0
• Support Opportunities: Regular Research Grants
• Start date: February 01, 2019
• End date: January 31, 2022
• Field of knowledge: Health Sciences - Medicine - Medical Radiology
• Principal Investigator: Ricardo Miguel Costa de Freitas
• Grantee: Ricardo Miguel Costa de Freitas
• Host Institution: Instituto de Radiologia (InRad). Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• City of the host institution: São Paulo
• Associated researchers: Ana Amélia Fialho de Oliveira Hoff ; Angela Maria Sousa ; Carlos Alberto Buchpiguel ; José Guilherme Mendes Pereira Caldas ; Maria Candida Barisson Villares Fragoso

Abstract

RATIONALE: thyroid, adrenal, and neuroendocrine neoplasms have the potential to disseminate to bones. About 3% of patients with well-differentiated thyroid tumors develop secondary bone lesions, while adrenal or neuroendocrine tumors have an incidence of 10% and 13%, respectively. Vertebral metastases are associated with a poor prognosis. Systemic progressive disease, post-operative complications and pre-operative neurologic deficit were associated with worse overall survival rates in thyroid cancer. Additionally, more invasive surgeries in vertebral metastases from thyroid carcinoma were related to higher complication rates. Interventional radiology offers promising minimally invasive techniques to approach bone metastases. Percutaneous image-guided radiofrequency or cryoablation techniques have been studied in clinical trials and are considered effective options in pain palliation of patients with bone metastatic disease. These techniques can be offered together with conventional treatments such as percutaneous embolization or external beam radiation therapy and prevent patients from invasive surgery and its related complications.PURPOSE: evaluate the clinical response and safety of percutaneous cone beam computed tomography guided cryoablation of bone metastases from thyroid, adrenal or neuroendocrine tumors.DESIGN: prospective, single-arm, single-center, non-randomized phase II study.METHODS: 30 patients with bone metastatic lesions from thyroid, adrenal or neuroendocrine tumors will be enrolled. Inclusion criteria are: patients with bone lesions associated with pain, fracture or spinal cord compression risk; hipercalcemia; patients over 18 years old, with performance status (ECOG) 0, 1, 2 or 3 and average life expectancy over one month. Patients under 18 years old, with uncorrectable coagulopathy or taking anticoagulant therapy, pregnant or breastfeeding women will be excluded from the study.PRIMARY END-POINTS: 1. Evaluation of clinical results from percutaneous cryoablation of bone metastases from thyroid, adrenal or neuroendocrine tumors and their related musculoskeletal events: need of external beam radiation therapy or surgery; decrease in complication rates secondary to stabilization of local bone disease; pain control in symptomatic patients; 2. Evaluation of pain control with the help of pain evaluation scores applied before and after the image-guided procedures.SECONDARY END-POINTS: evaluation of percutaneous cryoablation safety in the treatment of bone metastases from thyroid, adrenal or neuroendocrine tumors.SUBJECTS: 30 patients. (AU)