Cryoablation of Bone Metastases From Endocrine Tumors

Study Overview
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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.

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.

Official Title
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Cone-beam Computed Tomography Guided Percutaneous Cryoablation of Bone Metastases From Endocrine Tumors

Conditions
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Neoplasm Metastasis, Thyroid Neoplasm, Pheochromocytoma, Adrenal Neoplasm, Neuroendocrine Tumors, Bone Metastases

Intervention / Treatment
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* Device: cryoablation


Participation Criteria
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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; Exclusion Criteria: age < 18 years active anticoagulant therapy or uncorrectable coagulopathy pregnancy or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: open, single-arm group, prospective
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cryoablation +- cementoplasty treated patients<br>cone beam computed tomography guided cryoablation +- cementoplasty | Device: cryoablation<br>* cryoablation of bone metastases by cone beam-CT image-guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of pain control | evaluation of pain control with the help of Brief Pain Inventory forms | 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 | 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); | 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 | 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 | baseline (preprocedure); immediate post-procedure; 06 months |