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出境医 / 临床实验 / Cryoablation of Bone Metastases From Endocrine Tumors

Cryoablation of Bone Metastases From Endocrine Tumors

Study Description
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.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Thyroid Neoplasm Pheochromocytoma Adrenal Neoplasm Neuroendocrine Tumors Bone Metastases Device: cryoablation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open, single-arm group, prospective
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cone-beam Computed Tomography Guided Percutaneous Cryoablation of Bone Metastases From Endocrine Tumors
Actual Study Start Date : September 26, 2019
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : June 15, 2023
Arms and Interventions
Arm Intervention/treatment
Cryoablation +- cementoplasty treated patients
cone beam computed tomography guided cryoablation +- cementoplasty
 Device: cryoablation
cryoablation of bone metastases by cone beam-CT image-guidance
Outcome Measures
Primary Outcome Measures :
  1. change in the local disease status of the cryoablation treated bone metastases [ Time Frame: 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 :
  1. evaluation of pain control [ Time Frame: 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

  2. evaluation of quality of life [ Time Frame: 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

  3. number of participants with treatment-related adverse events according to CTCAE 5.0 [ Time Frame: 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);

  4. imaging evaluation (CT or MRI) [ Time Frame: baseline (preprocedure); 03 months, 06 months, 12 months, 24 months ]
    Computed tomography or Magnetic resonance imaging evaluation of eligible treated lesions

  5. functional imaging evaluation (PET-CT) [ Time Frame: baseline (preprocedure); immediate post-procedure; 06 months ]
    Computed tomography or Magnetic resonance imaging evaluation of eligible treated lesions


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Ricardo MC Freitas, PhD 551138932945 ricardo.freitas@hc.fm.usp.br
Contact: Ana O Hoff, PhD 551138932945 ana.hoff@hc.fm.usp.br

Locations
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Brazil
Instituto do Cancer do Estado de São Paulo Recruiting
São Paulo, Brazil, 01246000
Contact: Talita R Vincunas    551138932945    talita.vincunas@hc.fm.usp.br   
Contact: Ricardo MC Freitas, PhD    551138932945    ricardo.freitas@hc.fm.usp.br   
Principal Investigator: Ricardo MC Freitas, PhD         
Sub-Investigator: Ana O Hoff, PhD         
Sub-Investigator: Maria Candida VB Fragoso, PhD         
Sub-Investigator: Jose Guilherme MP Caldas, PhD         
Sub-Investigator: Carlos A Buchpiguel, PhD         
Sub-Investigator: Angela M Sousa, PhD         
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Ricardo MC Freitas, PhD Instituto do Cancer do Estado de São Paulo
Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date July 29, 2020
Actual Study Start Date  ICMJE September 26, 2019
Estimated Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019) 		change in the local disease status of the cryoablation treated bone metastases [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • evaluation of pain control [ Time Frame: 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 [ Time Frame: 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
  • number of participants with treatment-related adverse events according to CTCAE 5.0 [ Time Frame: 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);
  • imaging evaluation (CT or MRI) [ Time Frame: 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) [ Time Frame: baseline (preprocedure); immediate post-procedure; 06 months ]
    Computed tomography or Magnetic resonance imaging evaluation of eligible treated lesions
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cryoablation of Bone Metastases From Endocrine Tumors
Official Title  ICMJE Cone-beam Computed Tomography Guided Percutaneous Cryoablation of Bone Metastases From Endocrine Tumors
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
open, single-arm group, prospective
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasm Metastasis
  • Thyroid Neoplasm
  • Pheochromocytoma
  • Adrenal Neoplasm
  • Neuroendocrine Tumors
  • Bone Metastases
Intervention  ICMJE Device: cryoablation
cryoablation of bone metastases by cone beam-CT image-guidance
Study Arms  ICMJE Cryoablation +- cementoplasty treated patients
cone beam computed tomography guided cryoablation +- cementoplasty
Intervention: Device: cryoablation
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.
  • 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. Review.
  • Ferrer-Mileo L, Luque Blanco AI, González-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2023
Estimated Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ricardo MC Freitas, PhD 551138932945 ricardo.freitas@hc.fm.usp.br
Contact: Ana O Hoff, PhD 551138932945 ana.hoff@hc.fm.usp.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986593
Other Study ID Numbers  ICMJE 990/2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
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.
Responsible Party Instituto do Cancer do Estado de São Paulo
Study Sponsor  ICMJE Instituto do Cancer do Estado de São Paulo
Collaborators  ICMJE University of Sao Paulo General Hospital
Investigators  ICMJE
Principal Investigator: Ricardo MC Freitas, PhD Instituto do Cancer do Estado de São Paulo
PRS Account Instituto do Cancer do Estado de São Paulo
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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