Cryoablation of Bone Metastases From Endocrine Tumors

NCT03986593 | Terminated DMC FDA Device

• 1 other identifier: 990/2016
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• evaluation of pain control

  baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months

• evaluation of quality of life

  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

  baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months

• imaging evaluation (CT or MRI)

  baseline (preprocedure); 03 months, 06 months, 12 months, 24 months

• functional imaging evaluation (PET-CT)

  baseline (preprocedure); immediate post-procedure; 06 months

Study Arms (1)

Cryoablation +- cementoplasty treated patients

OTHER

cone beam computed tomography guided cryoablation +- cementoplasty

Device: cryoablation

Interventions

cryoablation DEVICE

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

Cryoablation +- cementoplasty treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• University of Sao Paulo General Hospital: collaborator

Study Sites (1)

Instituto do Cancer do Estado de São Paulo

São Paulo, 01246000, Brazil

Location

Related Publications (6)

• 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.

  PMID: 21170528 BACKGROUND

• 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.

  PMID: 12091666 BACKGROUND

• 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.

  PMID: 21500132 BACKGROUND

• 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.

  PMID: 29734509 BACKGROUND

• 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.

  PMID: 23065947 BACKGROUND

• de Freitas RMC, Hoff AO, Fragoso MCBV, Sousa AM, Danilovic DLS, de Castroneves LA, Grigio TR, Tsunemi MH, Buchpiguel CA, Caldas JGMP. Cryoablation of bone metastases in thyroid and adrenocortical cancers. Endocr Relat Cancer. 2026 Jan 30;33(1):e250306. doi: 10.1530/ERC-25-0306. Print 2026 Jan 1.

  PMID: 41543023 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Thyroid Neoplasms; Pheochromocytoma; Adrenal Gland Neoplasms; Neuroendocrine Tumors

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Paraganglioma; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Adrenal Gland Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Ricardo MC Freitas, PhD

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open, single-arm group, prospective

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 14, 2019
• Study Start: September 26, 2019
• Primary Completion: October 15, 2022
• Study Completion: May 29, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-05

Data Sharing

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

Locations

BR (1)