Bone metastases treatment by image-guided freezing in patients with endocrine tumors

Not Applicable

• Conditions: Bone metastases; thyroid gland neoplasms; pheochromocytoma; neuroendocrine carcinomas; C04.697.650; C04.588.322.894; C04.557.465.625.650.700.725; C04.557.465.625.650.240

• Registration Number: RBR-22zvxw
• Lead Sponsor: Instituto de Radiologia do Hospital das Clínicas / Faculdade de Medicina da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

age bellow 18 years-old; active anticoagulant treatment
non-conclusive or benign cytologic specimens
pregnancy or breast-feeding undifferentiated thyroid neoplasia (anaplastic)

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
clinical endpoints of percutaneous cryoablation in the treatment of bone metastases: major complication rates (less than 5%);