This study will evaluate the clinical response and safety of cone beam computed-tomography guided percutaneous cryoablation in bone metastases from thyroid, adrenal and neuroendocrine tumors in 30 patients.
Thyroid neoplasms, as well as adrenal and neuroendocrine tumors have the potential to metastasize to bone. About 3% of patients with well-differentiated thyroid carcinomas develop secondary bone lesions, while adrenal and neuroendocrine tumors have 10% and 13% bone metastases rates, respectively. Spinal metastases are associated to a worst prognosis. The progressive systemic disease, the post-operative complications, and the pre-operative neurologic impairment were associated to a worst global survival rate in the thyroid cancer. Additionally, extensive spinal instrumentation of metastatic thyroid carcinoma was associated to greater complication rates. Interventional radiology offers promising techniques for the minimally invasive approach of bone metastases. Image-guided percutaneous radiofrequency ablation and cryoablation techniques have been studied in clinical trials and are considered effective options in pain palliation of patients with bone metastatic disease. These techniques may be associated with conventional treatment, as well as radiation therapy and percutaneous embolization, avoiding major surgical interventions and its complications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
cryoablation of bone metastases by cone beam-CT image-guidance
Instituto do Cancer do Estado de São Paulo
São Paulo, Brazil
change in the local disease status of the cryoablation treated bone metastases
absence of neurological impairment and/or pain evaluated by clinical examination and brief pain inventory forms avoiding additional radiation therapy or surgery need
Time frame: baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months
evaluation of pain control
evaluation of pain control with the help of Brief Pain Inventory forms
Time frame: baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months
evaluation of quality of life
evaluation of quality of life with the help of Brief Pain Inventory forms
Time frame: baseline (preprocedure), 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months
number of participants with treatment-related adverse events according to CTCAE 5.0
Major complications rates below 10%; Minor complication rates below 15%; Side effects rates bellow 20%; according to general guidelines (Society of Interventional Radiology - SIR);
Time frame: baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months
imaging evaluation (CT or MRI)
Computed tomography or Magnetic resonance imaging evaluation of eligible treated lesions
Time frame: baseline (preprocedure); 03 months, 06 months, 12 months, 24 months
functional imaging evaluation (PET-CT)
Computed tomography or Magnetic resonance imaging evaluation of eligible treated lesions
Time frame: baseline (preprocedure); immediate post-procedure; 06 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.