Cryoablation of Bone Metastases From Endocrine Tumors

Not Applicable

Terminated

• Conditions: Thyroid Neoplasm; Adrenal Neoplasm; Neoplasm Metastasis; Pheochromocytoma; Neuroendocrine Tumors; Bone Metastases
• Interventions: Device: cryoablation

• Registration Number: NCT03986593
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-14
• Study Start: 2019-09-26
• Primary Completion: 2022-10-15
• Status Verified: 2023-05
• Study Completion: 2023-05-29
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryoablation +- cementoplasty treated patients	cryoablation	cone beam computed tomography guided cryoablation +- cementoplasty

Primary Outcome Measures

Name	Time	Method
change in the local disease status of the cryoablation treated bone metastases	baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months	absence of neurological impairment and/or pain evaluated by clinical examination and brief pain inventory forms avoiding additional radiation therapy or surgery need

Secondary Outcome Measures

Name	Time	Method
number of participants with treatment-related adverse events according to CTCAE 5.0	baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months	Major complications rates below 10%; Minor complication rates below 15%; Side effects rates bellow 20%; according to general guidelines (Society of Interventional Radiology - SIR);
evaluation of pain control	baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months	evaluation of pain control with the help of Brief Pain Inventory forms
evaluation of quality of life	baseline (preprocedure), 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months	evaluation of quality of life with the help of Brief Pain Inventory forms
imaging evaluation (CT or MRI)	baseline (preprocedure); 03 months, 06 months, 12 months, 24 months	Computed tomography or Magnetic resonance imaging evaluation of eligible treated lesions
functional imaging evaluation (PET-CT)	baseline (preprocedure); immediate post-procedure; 06 months	Computed tomography or Magnetic resonance imaging evaluation of eligible treated lesions

Trial Locations

Locations (1)

Instituto do Cancer do Estado de São Paulo; 🇧🇷 São Paulo, Brazil