Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cryoablation of Bone Metastases From Endocrine Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03986593
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
University of Sao Paulo General Hospital
Information provided by (Responsible Party):
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.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Estimated Study Start Date : August 6, 2019
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : June 15, 2023


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986593


Contacts
Layout table for location contacts
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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Ricardo MC Freitas, PhD Instituto do Cancer do Estado de São Paulo

Publications:
Layout table for additonal information
Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT03986593     History of Changes
Other Study ID Numbers: 990/2016
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Neoplasms, Second Primary
Neuroendocrine Tumors
Bone Neoplasms
Pheochromocytoma
Thyroid Neoplasms
Endocrine Gland Neoplasms
Adrenal Gland Neoplasms
Bone Marrow Diseases
Neoplasms
Neoplastic Processes
Pathologic Processes
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Paraganglioma
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Adrenal Gland Diseases