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PainPhase 1NCT01461265

Safety and Efficacy of Cryoablation for the Palliation of Painful Bone Metastases

A Phase 1 study testing Cryoablation in people with Pain and Neoplasm Metastasis, run by Boston Scientific Corporation at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain associated with metastatic bone tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Neoplasm Metastasis
What is being tested?
Cryoablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
4 sitesin 3 countries
Study dates
Nov 2011to Apr 2015
Phase
Phase 1
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

  • 18 years of age or older
  • Metastatic bone disease with metastatic disease previously confirmed by prior biopsy; or Metastatic bone disease previously confirmed on imaging [e.g. computed tomography (CT) or magnetic resonance imaging (MRI)] with known (biopsied) primary disease (primary bone cancer is excluded)
  • Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
  • Unremitting pain that resulted in a return visit to the oncologist. The 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) despite pharmaceutical pain management
  • Pain must be from one or two painful metastatic sites in the bone that is amenable to cryoablation with CT or MRI (additional less painful metastatic sites may be present)
  • Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, MRI, or ultrasound (US) imaging
Show all 17Show fewer
  • Tumors must be suitable for cryoablation
  • Cryoablation should be performed within 14 days of baseline evaluations
  • Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)
  • Stable use of pain medications (no changes within 2 weeks prior to the cryoablation procedure)
  • ECOG (Eastern Cooperative Oncology Group) scale performance status 0-3
  • Life expectancy ≥ 2 months
  • Platelet count >50,000/mm³ within 6 weeks screening
  • INR (International Normalized Ratio) <1.5 within 6 weeks screening
  • No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
  • If taking antiplatelet or anticoagulation medication, it must be able to be discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin, ibuprofen, low molecular weight heparin preparations)
  • Clinically suitable for cryoablation therapy

Who cannot join

  • Leukemia, lymphoma, and myeloma
  • Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
  • Has undergone prior ablation treatment of the index tumor
  • Prior radiation therapy of the index tumor <3 weeks prior to screening
  • Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
  • Anticipated treatment of the index tumor that would require iceball formation within 1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava, bowel, or bladder
Show all 14Show fewer
  • Surgery at the tumor site or surgery involving the cryoablation-treated tumor (index tumor)
  • Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)
  • Patient currently with neutropenia (absolute neutrophil count <1000) within 6 weeks screening
  • Uncontrolled coagulopathy or bleeding disorders
  • Currently pregnant, nursing, or wishing to become pregnant during the study
  • Active, uncontrolled infection
  • Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to study entry
  • Concurrent participation in other experimental studies that could affect the primary endpoint

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

United States2 sites

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

Canada1 site

  • University of British Columbia

    Vancouver, British Columbia, V5Z 1L8

Other trials in Canada

France1 site

  • University Hospital of Strasbourg

    Strasbourg, F-67091

Other trials in France

About this study

Official title: Cryoablation for the Palliation of Painful Bone Metastases

This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain associated with metastatic bone tumors.

Read the detailed description

Patients with painful bone metastases who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy will be offered enrollment into the study. Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney).

Patients agreeing to participate will read and sign an informed consent form and thus become subjects in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Subjects will be followed for up to 24 weeks (6 months) for palliation of pain, quality of life and analgesic usage. Baseline and follow-up data will be collected for each subject via a web-based electronic data collection tool.

Being tested
Cryoablation
Keywords
Painful bone metastases, Bone metastases, Metastatic bone tumors, Metastatic bone pain, Cryoablation, Cryotherapy, Cryosurgery
Medical subject headings
Pain, Neoplasm Metastasis, Bone Neoplasms

What participants receive

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

  • CryoablationProcedure or surgery

    Also called Cryotherapy, Cryosurgery, Visual-ICE Cryoablation System, SeedNet Cryoablation System

    For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator.

Study groups in NCT01461265
Study groupRoleWhat they receive
CryoablationOtherAll subjects will have cryoablation on one or two painful metastatic bone tumors.
Receives: Procedure: Cryoablation

What is being measured

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

  1. Difference in worst pain scores

    The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation associated with palliation of pain in subjects with metastatic bone cancer by measuring the average difference of pre- and posttreatment worst pain in 24 hours from baseline to 24 hour, 1, 4, 12, and 24 week follow-up intervals as measured on the numeric 0 to 10 Brief Pain Inventory (BPI) scale.

    Measured: 24 weeks post-cryoablation

Secondary outcomes (8)

  1. Cryoablation retreatments

    If the first cryoablation procedure effectively relieves pain but the relief wears off over time and the pain becomes unbearable, a second procedure may be performed. The number of repeat cryoablation treatments will be recorded.

    Measured: 24 weeks post-cryoablation

  2. Additional surgical treatments other than cryoablation

    If pain is not effectively relieved by the cryoablation, other surgical treatments may be performed. The number of these treatments will be recorded.

    Measured: 24 weeks post-cryoablation

  3. Reduced analgesic usage

    The number of subjects (percentage) who are able to reduce analgesic medications from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation will be recorded.

    Measured: 24 weeks post-cryoablation

  4. Time to maximal palliation of pain after cryoablation

    The difference in pain scores will be assessed from baseline to follow-up intervals after cryoablation will be analyzed. The interval indicating the most relief from pain will be compared across subjects.

    Measured: 24 weeks post-cryoablation

  5. Subject satisfaction with the amount palliation of pain obtained from cryoablation

    Subject satisfaction will be compared at baseline to follow-up intervals.

    Measured: 24 weeks post-cryoablation

  6. Number of adverse events

    The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure.

    Measured: 30 days post-cryoablation

  7. Difference in average pain scores

    Difference in average pain scores from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation as measured on the numeric 0 to 10 BPI scale

    Measured: 24 weeks post-cryoablation

  8. Time to recurrence of worst pain

    Time to recurrence of worst pain at or above baseline; worst pain score in the 24 week follow-up period as measured on the numeric 0 to 10 BPI scale

    Measured: 24 weks post-cryoablation

Timeline

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

  1. First posted28 Oct 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionApr 2015
  4. Study completionApr 2015

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 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01461265
Sponsor's protocol ID
CUC10-BNE11
Status last verified
Jul 2021
First submitted
25 Oct 2011
Last updated
16 Jul 2021
Results posted
No
Data monitoring committee
No

Publications

  • Callstrom MR, Atwell TD, Charboneau JW, Farrell MA, Goetz MP, Rubin J, Sloan JA, Novotny PJ, Welch TJ, Maus TP, Wong GY, Brown KJ. Painful metastases involving bone: percutaneous image-guided cryoablation--prospective trial interim analysis. Radiology. 2006 Nov;241(2):572-80. doi: 10.1148/radiol.2412051247.

    PubMed 17057075

  • Coleman RE. Management of bone metastases. Oncologist. 2000;5(6):463-70. doi: 10.1634/theoncologist.5-6-463.

    PubMed 11110597

  • Goetz MP, Callstrom MR, Charboneau JW, Farrell MA, Maus TP, Welch TJ, Wong GY, Sloan JA, Novotny PJ, Petersen IA, Beres RA, Regge D, Capanna R, Saker MB, Gronemeyer DH, Gevargez A, Ahrar K, Choti MA, de Baere TJ, Rubin J. Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol. 2004 Jan 15;22(2):300-6. doi: 10.1200/JCO.2004.03.097.

    PubMed 14722039

  • 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

  • Simon CJ, Dupuy DE. Percutaneous minimally invasive therapies in the treatment of bone tumors: thermal ablation. Semin Musculoskelet Radiol. 2006 Jun;10(2):137-44. doi: 10.1055/s-2006-939031. Epub 2006 Apr 5.

    PubMed 16598666

  • Ullrick SR, Hebert JJ, Davis KW. Cryoablation in the musculoskeletal system. Curr Probl Diagn Radiol. 2008 Jan-Feb;37(1):39-48. doi: 10.1067/j.cpradiol.2007.05.001.

    PubMed 18054665

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cryoablation in people with Pain and Neoplasm Metastasis, run by Boston Scientific Corporation at 4 sites in 3 countries.

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 17 inclusion and 14 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: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada, France. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Difference in worst pain scores (time frame: 24 weeks post-cryoablation). 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 NCT01461265, 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 16 Jul 2021.

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