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Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases (MOTION)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02511678
First Posted: July 30, 2015
Last Update Posted: October 10, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Galil Medical
  Purpose
This study will evaluate the efficacy of cryoablation for palliation of painful metastases in patients with metastatic lesions involving bone who have failed, are not candidates for, or are not experiencing adequate pain relief from current pain therapies (e.g. radiation, analgesics).

Condition Intervention
Pain Neoplasm Metastasis Procedure: Cryoablation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

Resource links provided by NLM:


Further study details as provided by Galil Medical:

Primary Outcome Measures:
  • Difference in worst pain scores [ Time Frame: 8 weeks post-cryoablation ]
    The primary endpoint for this study will be measured as follows: improvement in self-reported pain scores defined by ≥ 2 point reduction in worst pain in the last 24 hours using the Brief Pain Inventory (BPI) from baseline to 8 weeks. A mean difference of 2 points reduction is considered clinically significant.


Other Outcome Measures:
  • Number of subjects who respond to the cryoablation therapy [ Time Frame: 8 weeks post-cryoablation ]
    A responder is defined as a subject having ≥ 2 point reduction in the worst pain score in the last 24 hours using the BPI and no more than 25% increase in medication use (morphine equivalent) from baseline to 8 weeks

  • Quality of Life (QoL) [ Time Frame: Up to 24 weeks post-cryoablation ]
    Quality of Life (QoL) as measured by the overall BPI pain interference average score from baseline to 1, 4, 8, 12, 16, 20, and 24 weeks after cryoablation

  • Number of patients with a change in physical function [ Time Frame: Up to 24 weeks post-cryoablation ]
    Change in physical function as measured by Karnofsky Performance Status (KPS) from baseline to 1, 4, 8, 12, 16, 20, and 24 weeks after cryoablation

  • Number of patients with additional therapies [ Time Frame: Up to 24 weeks post-cryoablation ]
    Additional therapies for persistent/recurrent pain associated with the index tumor under study or new bone metastases through 24 weeks

  • Number of patients with a change in analgesic medications [ Time Frame: Up to 24 weeks post-cryoablation ]
    Change in analgesic medications [morphine equivalent daily dosing and nonsteroidal antiinflammatory drug (NSAID) use] from baseline to 1, 4, 8, 12, 16, 20, and 24 weeks after cryoablation

  • Difference in worst pain scores [ Time Frame: Up to 24 weeks post-cryoablation ]
    Difference in worst pain scores from baseline to 1, 4, 12, 16, 20, and 24 weeks after cryoablation as measured on the numeric 0 to 10 BPI scale

  • Difference in average pain scores [ Time Frame: Up to 24 weeks post-cryoablation ]
    Difference in average pain scores from baseline to 1, 4, 8, 12, 16, 20, and 24 weeks after cryoablation as measured on the BPI numeric rating scale

  • Self-assessed Overall Treatment Effect (OTE) [ Time Frame: Up to 24 weeks post-cryoablation ]
    Self-assessed Overall Treatment Effect (OTE) at 1, 4, 8, 12, 16, 20, and 24 weeks after cryoablation

  • Number of adverse events [ Time Frame: Up to 30 days post-cryoablation ]
    The safety endpoint for this study is to assess the incidence and severity of procedure or device- related adverse events


Enrollment: 65
Actual Study Start Date: February 15, 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cryoablation
All subjects will have one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles.
Procedure: Cryoablation
Cryoablation is an FDA-cleared technology for selective ablation and treatment of different kinds of benign and malignant conditions. 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.
Other Names:
  • Cryotherapy
  • Cryosurgery
  • Visual-ICE Cryoablation System
  • IceSeed Cryoablation Needle
  • IceSphere Cryoablation Needle
  • IceRod PLUS Cryoablation Needle
  • IceEDGE 2.4 Cryoablation Needle
  • IceFORCE 2.1 Cryoablation Needle
  • IcePearl 2.1 Cryoablation Needle

Detailed Description:
Patients with painful metastatic lesions involving bone 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. 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 have one cryoablation procedure and will be followed for up to 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.
  Eligibility

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.


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

Inclusion Criteria:

  • 18 years of age or older
  • Metastatic disease involving bone with metastatic disease previously confirmed by prior biopsy; or Metastatic disease involving bone previously confirmed on imaging (e.g. CT or MRI) with known (biopsied) primary disease (primary bone cancer is excluded)
  • Current analgesic therapies have failed, the subject is not a candidate for, OR the subject is not experiencing adequate pain relief from current pain therapies (e.g. radiation, analgesics)
  • 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)
  • Pain must be from one painful metastatic lesion involving the bone that is amenable to cryoablation with CT (additional less painful metastatic sites may be present)
  • Cryoablation should be performed within 14 days of screening visit
  • If taking hormonal therapy, use should be stable (no changes within 4 weeks prior to the cryoablation procedure)
  • Karnofsky Performance Scale (KPS) score ≥60
  • Life expectancy ≥ 3 months
  • No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
  • Known coagulopathy or bleeding disorders are controlled

Exclusion Criteria:

  • Primary cancer is leukemia, lymphoma, or myeloma
  • Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
  • Has undergone prior surgery at the tumor site or the index tumor has undergone previous surgery or ablation treatment
  • Prior radiation therapy of the index tumor <3 weeks prior to the screening visit
  • 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 0.5 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel (possibly achieved with additional maneuvers such as hydrodissection)
  • Index tumor involves the skull
  • Currently pregnant, nursing, or wishing to become pregnant during the study
  • Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit
  • Concurrent participation in other studies that could affect the primary endpoint
  Contacts and Locations
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): NCT02511678


Locations
United States, California
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Crittenton Hospital
Rochester, Michigan, United States, 48307
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
France
Institut Bergonié
Bordeaux, France, 33000
Centre Léon Bérard
Lyon, France, 69373
University Hospital of Strasbourg
Strasbourg, France, 67091
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Galil Medical
Investigators
Principal Investigator: Jack Jennings, MD Washington University Saint Louis
  More Information

Additional Information:
Publications:

Responsible Party: Galil Medical
ClinicalTrials.gov Identifier: NCT02511678     History of Changes
Other Study ID Numbers: CGC15-BNE098
First Submitted: July 27, 2015
First Posted: July 30, 2015
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes