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

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ClinicalTrials.gov Identifier: NCT02511678
Recruitment Status : Completed
First Posted : July 30, 2015
Results First Posted : September 4, 2019
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Galil Medical, a wholly owned indirect subsidiary of Boston Scientific

Brief Summary:
This study will evaluate the efficacy of cryoablation for palliation of painful metastases in participants with metastatic lesions involving bone who have failed, are not candidates for, or are not experiencing adequate pain relief from current pain therapies (for example, radiation, analgesics).

Condition or disease Intervention/treatment Phase
Pain Neoplasm Metastasis Bone Metastasis of Diverse Origins Device: Cryoablation Not Applicable

Detailed Description:
Participants with painful metastatic lesions involving bone who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy were offered enrollment into the study. Participants agreeing to participate will read and sign an informed consent form and thus become participants in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Participants 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 participant via a web-based electronic data collection tool.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases
Actual Study Start Date : February 15, 2016
Actual Primary Completion Date : March 12, 2018
Actual Study Completion Date : March 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: Cryoablation
All participants will have one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion is to be selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant will be re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure will be identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and will be at the discretion of the Investigators.
Device: Cryoablation
The application of repeated freeze and thaw cycles to the identified tissues.
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




Primary Outcome Measures :
  1. Change From Baseline in Worst Pain Scores as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) at Week 8 [ Time Frame: Baseline, Week 8 ]
    The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported worst pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Improvement in self-reported pain scores is defined by ≥2-point reduction in worst pain. A mean difference of a 2-point reduction is considered clinically significant, that is improvement. Baseline data and change from Baseline data at Week 8 is presented.


Other Outcome Measures:
  1. Percentage of Participants Who Respond to the Cryoablation Therapy [ Time Frame: Baseline and Week 8 ]
    Response was defined as a ≥2-point reduction from baseline in worst pain in last 24 hours with stable medication use (that is, no more than a 25% increase in Morphine Equivalent Daily Dose [MEDD] from baseline). MEDD is calculated using the following formula: [Dose]*[MEDD Factor]. MEDD Factor is based on the type and dose of the opioid received. Pain was assessed using BPI-SF with a scale of 0 (no pain) to 10 (worst pain imaginable). Percentages are proportion of responders based on logistic regression after MCMC, multiple imputation. For visits where medication use is not available, morphine equivalent values from the most recent non-missing visit are used.

  2. Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24. [ Time Frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 ]
    Quality of Life (QoL) as indicated by the change in overall average BPI-SF Pain Interference score from baseline to each visit was evaluated at Weeks 1, 4, 8, 12, 16, 20, and 24. Using the BPI-SF, participants rated the amount of interference from pain on a scale of 0 (does not interfere) to 10 (completely interferes) for the following areas: general activity. mood, walking ability, relations, sleep, and enjoyment. For participants with responses ≥50% of the areas at a time point, a total Pain Interference score, which was the mean of the individual area scores, was calculated programmatically at that point. Baseline data and change from Baseline data is presented.

  3. Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24 [ Time Frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 ]
    The Karnofsky Performance Status (KPS) scale is a standard way of measuring the ability of cancer participants to perform ordinary tasks. KPS may be used to determine a participant's prognosis and to measure changes in a participant's ability to function. Assessments made by examining the change in the baseline scores to those reported post-operatively. KPS scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities from Baseline to 1, 4, 8, 12, 16, 20, and 24 weeks after cryoablation. Baseline data and change from Baseline data is presented.

  4. Number of Participants With Additional Pain Therapies [ Time Frame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 ]
    Participants requiring additional targeted therapies to the index tumor (for example, cryoablation, radio frequency ablation [RFA], microwave ablation [MWA], high intensity focused ultrasound [HIFU], radiation, surgery) were withdrawn from the study. Other therapies, including pain medication and chemotherapy, were permitted during the study. All additional therapies were recorded. The number of participants requiring new therapy since the last visit is presented.

  5. Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24 [ Time Frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 ]
    Analgesic (that is, opioid or non-steroidal anti-inflammatory drug [NSAID]) use and the reason for each change in analgesic dose was recorded at each study visit. Opioid medications were converted to a standardized MEDD. MEDD is calculated using the following formula: [Dose]*[MEDD Factor]. MEDD Factor is based on the type and dose of the opioid received. Baseline data and change from Baseline data is presented.

  6. Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24 [ Time Frame: Baseline, Week 1, Week 4, Week 12, Week 16, Week 20, and Week 24 ]
    The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported worst pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Improvement in self-reported pain scores is defined by ≥2-point reduction in worst pain. A mean difference of a 2 point reduction is considered clinically significant, that is improvement. Baseline data and change from Baseline data at Weeks 1, 4, 12, 16, 20, and 24 is presented.

  7. Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24 [ Time Frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 ]
    The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported average pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Baseline data and change from Baseline data is presented.

  8. Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24 [ Time Frame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 ]
    Participants performed a self-assessment of OTE at Week 1 and every visit thereafter (Weeks 4, 8, 12, 16, 20 and 24). Participants were asked their opinion of the effect cryoablation procedure had on their wellbeing and asked to compare their wellbeing at the time of each follow-up visit to the previous visit or phone call. The wellbeing categories were "Better than the Last Visit," "The Same as the Last Visit," and "Worse than the Last Visit." The percentage of participants that were reported for each wellbeing category at Weeks 1, 4, 8, 12, 16, 20, and 24 is presented.

  9. Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects [ Time Frame: Baseline up to 30 days post-cryoablation ]
    The number of participants with an intra-operative non-serious adverse event, a post-operative, a non-serious adverse event, a serious adverse event, or unanticipated adverse device effects related to the cryoablation procedure is presented. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.



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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:

  • 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 (for example, computed tomography [CT] or magnetic resonance imaging [MRI]) with known (biopsied) primary disease (primary bone cancer is excluded)
  • Current analgesic therapies have failed, the participant is not a candidate for, or the participant is not experiencing adequate pain relief from current pain therapies (for example, 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 participant 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 centimeters (cm) of the spinal cord, brain, other critical nerve structure, or 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, or cerebrovascular event within 6 months prior to the screening visit
  • Concurrent participation in other studies that could affect the primary endpoint

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
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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, a wholly owned indirect subsidiary of Boston Scientific
Investigators
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Principal Investigator: Jack Jennings, MD Washington University Saint Louis
  Study Documents (Full-Text)

Documents provided by Galil Medical, a wholly owned indirect subsidiary of Boston Scientific:
Study Protocol  [PDF] July 31, 2017
Statistical Analysis Plan  [PDF] May 18, 2016

Additional Information:
Publications:

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Responsible Party: Galil Medical, a wholly owned indirect subsidiary of Boston Scientific
ClinicalTrials.gov Identifier: NCT02511678    
Other Study ID Numbers: CGC15-BNE098
First Posted: July 30, 2015    Key Record Dates
Results First Posted: September 4, 2019
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases