Cryoablation of Bone Metastases From Endocrine Tumors

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03986593
• Other study ID #: 990/2016
• Status: Terminated
• Phase: N/A
• Start date: September 26, 2019
• Est. completion date: May 29, 2023

Study information

• Verified date: May 2023
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: May 29, 2023
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Adrenal Neoplasm
• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Endocrine Gland Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Neuroendocrine Tumors
• Pheochromocytoma
• Thyroid Neoplasm
• Thyroid Neoplasms

Intervention

Device:
• cryoablation
cryoablation of bone metastases by cone beam-CT image-guidance

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo	University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	functional imaging evaluation (PET-CT)	Computed tomography or Magnetic resonance imaging evaluation of eligible treated lesions	baseline (preprocedure); immediate post-procedure; 06 months