Bone metastases
Conditions
Interventions
Cone-beam computed tomography guided percutaneous cryoablation with or without percutaneous cementoplasty (depending on lesion location - if weight-bearing site or not).
All patients must have symptom
Procedure/surgery
E02.258
E02.718.275.500
Sponsors
Instituto de Radiologia do Hospital das Clínicas / Faculdade de Medicina da Universidade de São Paulo
Instituto do Câncer do Estado de São Paulo - ICESP
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: patients with bone metastases diagnosis evidenced by imaging exams (CT, MRI and/or PET-CT) and secondary to: papillary, folicular or medullary thyroid cancer; adrenal carcinoma; neuroendocrine carcinomas; metastatic bone lesions associated with: pain; risk of fracture; risk of spinal cord compression; hypercalcemia; age over or equal 18 years old; performance status (ECOG) of 0, 1, 2 or 3; life expectation over one month; patients must present pain symptoms from bone metastases and / or localized in a region of imminent risk of instability / fracture that may progress to neurological complication (for example, vertebral metastases) or functional impairment (for example, acetabular metastases); all patients must present diagnosis confirmation from metastases biopsy; the same treated patients can be treated again if they present new lesions during the study; all patients must be evaluated for treatment indication by a multidisciplinary team; the metastatic lesions may be located at the axial skeleton, costal arches, shoulder or pelvic girdle; each bone metastases assigned for treatment must be biopsy-proven and / or presenting elevation of thyroglobulin or calcitonin levels in the needle wash, if thyroid carcinoma is present; all patients must present five symptomatic bone metastases maximum; all selected metastases must have 7.0 cm diameter maximum;
Exclusion criteria
Exclusion criteria: age bellow 18 years-old; active anticoagulant treatment non-conclusive or benign cytologic specimens pregnancy or breast-feeding undifferentiated thyroid neoplasia (anaplastic)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical endpoints of percutaneous cryoablation in the treatment of bone metastases: pain questionnaires (2 point reduction in pain score);;clinical endpoints of percutaneous cryoablation in the treatment of bone metastases: functional evaluation and quality of life (with preservation of ECOG functional score); ;clinical endpoints of percutaneous cryoablation in the treatment of bone metastases: opioid intake rate (more than 50% reduction); ;clinical endpoints of percutaneous cryoablation in the treatment of bone metastases: surgical conversion rate and external beam radiation therapy rate (less than 50% rate); ;clinical endpoints of percutaneous cryoablation in the treatment of bone metastases: ablation site recurrent disease rate (80% reduction); ;clinical endpoints of percutaneous cryoablation in the treatment of bone metastases: local progression free-survival (in months); | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical endpoints of percutaneous cryoablation in the treatment of bone metastases: major complication rates (less than 5%); | — |
Countries
Brazil
Contacts
Public ContactAlfredo Mansur
Comissão de Ética para Análise de Projetos de Pesquisa - CAPPesq
Outcome results
None listed