Cryoablation of Bone Metastases From Endocrine Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-26

Study Completion Date

2023-05-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neoplasm Metastasis Thyroid Neoplasm Pheochromocytoma Adrenal Neoplasm Neuroendocrine Tumors Bone Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

open, single-arm group, prospective

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cryoablation +- cementoplasty treated patients

cone beam computed tomography guided cryoablation +- cementoplasty

Group Type OTHER

cryoablation

Intervention Type DEVICE

cryoablation of bone metastases by cone beam-CT image-guidance

Interventions

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cryoablation

cryoablation of bone metastases by cone beam-CT image-guidance

Intervention Type DEVICE

Eligibility Criteria

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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;