Cryoablation of Bone Metastases From Endocrine Tumors

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

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.

Study Overview

• Status: Terminated
• Conditions: Neoplasm Metastasis; Neuroendocrine Tumors; Bone Metastases; Pheochromocytoma; Thyroid Neoplasm; Adrenal Neoplasm
• Intervention / Treatment: Device: cryoablation

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01246000
    • Instituto do Cancer do Estado de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo
• Collaborators: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Ricardo MC Freitas, PhD, Instituto do Cancer do Estado de Sao Paulo

Publications and helpful links

General Publications

• de Freitas RM, de Menezes MR, Cerri GG, Gangi A. Sclerotic vertebral metastases: pain palliation using percutaneous image-guided cryoablation. Cardiovasc Intervent Radiol. 2011 Feb;34 Suppl 2:S294-9. doi: 10.1007/s00270-010-0085-7. Epub 2010 Dec 18.
• Callstrom MR, Charboneau JW, Goetz MP, Rubin J, Wong GY, Sloan JA, Novotny PJ, Lewis BD, Welch TJ, Farrell MA, Maus TP, Lee RA, Reading CC, Petersen IA, Pickett DD. Painful metastases involving bone: feasibility of percutaneous CT- and US-guided radio-frequency ablation. Radiology. 2002 Jul;224(1):87-97. doi: 10.1148/radiol.2241011613.
• Munk PL, Murphy KJ, Gangi A, Liu DM. Fire and ice: percutaneous ablative therapies and cement injection in management of metastatic disease of the spine. Semin Musculoskelet Radiol. 2011 Apr;15(2):125-34. doi: 10.1055/s-0031-1275595. Epub 2011 Apr 15.
• Ferrer-Mileo L, Luque Blanco AI, Gonzalez-Barboteo J. Efficacy of Cryoablation to Control Cancer Pain: A Systematic Review. Pain Pract. 2018 Nov;18(8):1083-1098. doi: 10.1111/papr.12707. Epub 2018 Jun 7.
• Callstrom MR, Dupuy DE, Solomon SB, Beres RA, Littrup PJ, Davis KW, Paz-Fumagalli R, Hoffman C, Atwell TD, Charboneau JW, Schmit GD, Goetz MP, Rubin J, Brown KJ, Novotny PJ, Sloan JA. Percutaneous image-guided cryoablation of painful metastases involving bone: multicenter trial. Cancer. 2013 Mar 1;119(5):1033-41. doi: 10.1002/cncr.27793. Epub 2012 Oct 12.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): October 15, 2022
• Study Completion (Actual): May 29, 2023

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms by Site; Endocrine System Diseases; Hematologic Diseases; Musculoskeletal Diseases; Thyroid Diseases; Head and Neck Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplastic Processes; Bone Diseases; Adrenal Gland Diseases; Paraganglioma; Neoplasms; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases; Thyroid Neoplasms; Neuroendocrine Tumors; Endocrine Gland Neoplasms; Neoplasms, Second Primary; Pheochromocytoma; Adrenal Gland Neoplasms
• Other Study ID Numbers: 990/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Supporting information: Study protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code; Time frame: Data will be available within 18 months of study completion. Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

• IPD Sharing Time Frame: Data will become available within 18 months of study completion and for 6 months.
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes