Cryoablation of Bone Metastases From Endocrine Tumors

Instituto do Cancer do Estado de São Paulo

Status: Terminated

Conditions: Neuroendocrine Tumors; Thyroid Neoplasm; Neoplasm Metastasis; Bone Metastases; Adrenal Neoplasm; Pheochromocytoma

Treatments: Device: cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03986593

990/2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with bone metastases from thyroid, adrenal or neuroendocrine tumor diagnosis, associated to one of the following: pain; risk fracture; risk of compression of spinal cord; hypercalcemia; performance status (ECOG) 0-3; mean life expectancy over one month;

Exclusion criteria

• age < 18 years
• active anticoagulant therapy or uncorrectable coagulopathy
• pregnancy or breast feeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Cryoablation +- cementoplasty treated patients

Other group

Description:

cone beam computed tomography guided cryoablation +- cementoplasty

Treatment:

Device: cryoablation