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Neoplasm MetastasisNCT03986593

Cryoablation of Bone Metastases From Endocrine Tumors

A study testing cryoablation in people with Neoplasm Metastasis and Thyroid Neoplasm, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cryoablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteBrazil
Study dates
26 Sep 2019to 29 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto do Cancer do Estado de São Paulo

    São Paulo, 01246000

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
cryoablation
Medical subject headings
Neoplasm Metastasis, Thyroid Neoplasms, Pheochromocytoma, Adrenal Gland Neoplasms, Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cryoablationDevice

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

Study groups in NCT03986593
Study groupRoleWhat they receive
Cryoablation +- cementoplasty treated patientsOthercone beam computed tomography guided cryoablation +- cementoplasty
Receives: Device: cryoablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (5)

  1. evaluation of pain control

    evaluation of pain control with the help of Brief Pain Inventory forms

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

  2. evaluation of quality of life

    evaluation of quality of life with the help of Brief Pain Inventory forms

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

  3. 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);

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

  4. imaging evaluation (CT or MRI)

    Computed tomography or Magnetic resonance imaging evaluation of eligible treated lesions

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

  5. functional imaging evaluation (PET-CT)

    Computed tomography or Magnetic resonance imaging evaluation of eligible treated lesions

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2019
  2. Study start26 Sep 2019
  3. Primary completion15 Oct 2022
  4. Study completion29 May 2023

Why it stopped: The study achieved n=17 participants (56.6% of the initial proposition) with a mean = 18 months follow-up. All patients completed 12 months follow-up or deceased. We chose to terminate and publish the data available.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
open, single-arm group, prospective
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03986593
Sponsor's protocol ID
990/2016
Status last verified
May 2023
First submitted
22 May 2019
Last updated
5 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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.

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.

    PubMed 21170528

  • 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.

    PubMed 12091666

  • 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.

    PubMed 21500132

  • 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.

    PubMed 29734509

  • 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.

    PubMed 23065947

  • 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.

    PubMed 41543023

Questions about this trial

What is this clinical trial studying?

A study testing cryoablation in people with Neoplasm Metastasis and Thyroid Neoplasm, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study achieved n=17 participants (56.6% of the initial proposition) with a mean = 18 months follow-up. All patients completed 12 months follow-up or deceased. We chose to terminate and publish the data available.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03986593, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.

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