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MOTION: Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02511678
Collaborator
(none)
73
Enrollment
11
Locations
1
Arm
24.8
Actual Duration (Months)
6.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Cryoablation
 N/A

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.

Study Design

Study Type:
Interventional
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 :
Feb 15, 2016
Actual Primary Completion Date :
Mar 12, 2018
Actual Study Completion Date :
Mar 12, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    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 [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 [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. [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 [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 [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 [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA Ronald Reagan Medical Center Los Angeles California United States 90095
    2 Emory University Hospital Atlanta Georgia United States 30322
    3 Massachusetts General Hospital Boston Massachusetts United States 02114
    4 Crittenton Hospital Rochester Michigan United States 48307
    5 Mayo Clinic Rochester Rochester Minnesota United States 55905
    6 Washington University in St. Louis Saint Louis Missouri United States 63110
    7 Rhode Island Hospital Providence Rhode Island United States 02903
    8 Institut Bergonié Bordeaux France 33000
    9 Centre Léon Bérard Lyon France 69373
    10 University Hospital of Strasbourg Strasbourg France 67091
    11 Institut Gustave Roussy Villejuif France 94805

    Sponsors and Collaborators

    • Boston Scientific Corporation

    Investigators

    • Principal Investigator: Jack Jennings, MD, Washington University Saint Louis

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Boston Scientific Corporation
    ClinicalTrials.gov Identifier:
    NCT02511678
    Other Study ID Numbers:
    • CGC15-BNE098
    First Posted:
    Jul 30, 2015
    Last Update Posted:
    Jul 19, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Neoplasms, Second Primary
    Bone Neoplasms
    Bone Marrow Diseases

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Discontinuation reasons reported below of death, withdrew consent, oncologist cancelled study cryoablation, required radiofrequency ablation, negative biopsy, protocol violation, and received radiation treatment include 7 enrolled participants who were discontinued before treatment was attempted. No other data is reported for these 7 participants.
    Arm/Group Title Cryoablation
    Arm/Group Description All participants had 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 was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
    Period Title: Overall Study
    STARTED 73
    Intent-to-Treat (ITT) Population 66
    Participants Discontinued Pre-Treatment 7
    Safety Population 65
    COMPLETED 37
    NOT COMPLETED 36

    Baseline Characteristics

    Arm/Group Title Cryoablation
    Arm/Group Description All participants had 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 was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
    Overall Participants 66
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    60.8
    (14.3)
    Sex: Female, Male (Count of Participants)
    Female
    31
    47%
    Male
    35
    53%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    Not Hispanic or Latino
    34
    51.5%
    Unknown or Not Reported
    32
    48.5%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    8
    12.1%
    White
    27
    40.9%
    More than one race
    0
    0%
    Unknown or Not Reported
    31
    47%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Worst Pain Scores as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) at Week 8
    Description 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.
    Time Frame Baseline, Week 8

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population). The Markov chain Monte Carlo (MCMC) method of imputation was used for imputation of missing BPI-SF values with 50 imputations to be performed.
    Arm/Group Title Cryoablation
    Arm/Group Description All participants had 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 was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
    Measure Participants 66
    Baseline
    7.26
    (0.251)
    Change at Week 8
    -2.61
    (0.425)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cryoablation
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0746
    Comments The 1-sided p-value was based on a t-test against a performance goal of -2.
    Method t-test, 1 sided
    Comments
    2. Other Pre-specified Outcome
    Title Percentage of Participants Who Respond to the Cryoablation Therapy
    Description 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.
    Time Frame Baseline and Week 8

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population).
    Arm/Group Title Cryoablation
    Arm/Group Description All participants had 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 was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
    Measure Participants 66
    Number (95% Confidence Interval) [percentage of participants]
    42.1
    63.8%
    3. Other Pre-specified Outcome
    Title 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.
    Description 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.
    Time Frame Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable interference from pain scores.
    Arm/Group Title Cryoablation
    Arm/Group Description All participants had 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 was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
    Measure Participants 65
    General Activity, Baseline
    6.6
    (2.9)
    General Activity, Change at Week 1
    -1.6
    (3.8)
    General Activity, Change at Week 4
    -2.2
    (3.9)
    General Activity, Change at Week 8
    -2.4
    (4.0)
    General Activity, Change at Week 12
    -2.9
    (3.9)
    General Activity, Change at Week 16
    -3.3
    (4.0)
    General Activity, Change at Week 20
    -2.7
    (4.6)
    General Activity, Change at Week 24
    -3.4
    (3.5)
    Mood, Baseline
    5.1
    (2.9)
    Mood, Change at Week 1
    -1.3
    (3.4)
    Mood, Change at Week 4
    -2.0
    (3.7)
    Mood, Change at Week 8
    -2.4
    (3.1)
    Mood, Change at Week 12
    -2.7
    (3.1)
    Mood, Change at Week 16
    -2.7
    (3.5)
    Mood, Change at Week 20
    -2.4
    (3.9)
    Mood, Change at Week 24
    -2.6
    (3.4)
    Walking Ability, Baseline
    5.7
    (3.4)
    Walking Ability, Change at Week 1
    -1.7
    (3.4)
    Walking Ability, Change at Week 4
    -1.8
    (3.5)
    Walking Ability, Change at Week 8
    -1.4
    (3.4)
    Walking Ability, Change at Week 12
    -1.9
    (3.5)
    Walking Ability, Change at Week 16
    -2.5
    (3.3)
    Walking Ability, Change at Week 20
    -2.3
    (3.51)
    Walking Ability, Change at Week 24
    -2.3
    (2.9)
    Normal Work, Baseline
    6.4
    (3.2)
    Normal Work, Change at Week 1
    -1.2
    (3.5)
    Normal Work, Change at Week 4
    -2.6
    (4.1)
    Normal Work, Change at Week 8
    -2.1
    (4.0)
    Normal Work, Change at Week 12
    -2.5
    (4.6)
    Normal Work, Change at Week 16
    -3.2
    (4.4)
    Normal Week, Change at Week 20
    -2.5
    (4.6)
    Normal Week, Change at Week 24
    -3.0
    (3.7)
    Relations, Baseline
    4.0
    (3.1)
    Relations, Change at Week 1
    -1.8
    (3.2)
    Relations, Change at Week 4
    -1.7
    (3.7)
    Relations, Change at Week 8
    -1.5
    (3.2)
    Relations, Change at Week 12
    -2.2
    (3.2)
    Relations, Change at Week 16
    -2.4
    (3.3)
    Relations, Change at Week 20
    -2.5
    (3.8)
    Relations, Change at Week 24
    -2.4
    (3.1)
    Sleep, Baseline
    5.8
    (3.2)
    Sleep, Change at Week 1
    -2.2
    (3.1)
    Sleep, Change at Week 4
    -2.5
    (3.8)
    Sleep, Change at Week 8
    -2.3
    (3.3)
    Sleep, Change at Week 12
    -3.1
    (3.2)
    Sleep, Change at Week 16
    -4.1
    (3.4)
    Sleep, Change at Week 20
    -2.5
    (3.9)
    Sleep, Change at Week 24
    -3.0
    (3.9)
    Enjoyment, Baseline
    5.4
    (3.6)
    Enjoyment, Change at Week 1
    -1.9
    (3.4)
    Enjoyment, Change at Week 4
    -2.5
    (3.5)
    Enjoyment, Change at Week 8
    -2.2
    (3.4)
    Enjoyment, Change at Week 12
    -2.8
    (3.1)
    Enjoyment, Change at Week 16
    -3.4
    (3.5)
    Enjoyment, Change at Week 20
    -2.6
    (4.3)
    Enjoyment, Change at Week 24
    -3.3
    (3.2)
    Total Pain, Baseline
    5.5
    (2.5)
    Total Pain, Change at Week 1
    -1.7
    (2.6)
    Total Pain, Change at Week 4
    -2.2
    (3.1)
    Total Pain, Change at Week 8
    -2.0
    (2.8)
    Total Pain, Change at Week 12
    -2.6
    (2.8)
    Total Pain, Change at Week 16
    -3.1
    (2.8)
    Total Pain, Change at Week 20
    -2.5
    (3.2)
    Total Pain, Change at Week 24
    -2.9
    (2.3)
    4. Other Pre-specified Outcome
    Title Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24
    Description 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.
    Time Frame Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable KPS scores.
    Arm/Group Title Cryoablation
    Arm/Group Description 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.
    Measure Participants 66
    Baseline
    80.6
    (14.5)
    Change at Week 1
    -5.0
    (10.8)
    Change at Week 4
    -4.5
    (11.4)
    Change at Week 8
    -7.3
    (15.7)
    Change at Week 12
    -5.4
    (14.3)
    Change at Week 16
    -3.6
    (14.1)
    Change at Week 20
    -7.0
    (16.0)
    Change at Week 24
    -7.5
    (18.4)
    5. Other Pre-specified Outcome
    Title Number of Participants With Additional Pain Therapies
    Description 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.
    Time Frame Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable additional pain therapy data.
    Arm/Group Title Cryoablation
    Arm/Group Description All participants had 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 was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
    Measure Participants 66
    Week 1
    17
    25.8%
    Week 4
    30
    45.5%
    Week 8
    29
    43.9%
    Week 12
    24
    36.4%
    Week 16
    25
    37.9%
    Week 20
    21
    31.8%
    Week 24
    18
    27.3%
    6. Other Pre-specified Outcome
    Title Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
    Description 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.
    Time Frame Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable MEDD and NSAID data.
    Arm/Group Title Cryoablation
    Arm/Group Description All participants had 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 was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
    Measure Participants 66
    MEDD, Baseline
    31.365
    (69.9231)
    MEDD, Change at Week 1
    4.123
    (44.0061)
    MEDD, Change at Week 4
    5.884
    (55.6215)
    MEDD, Change at Week 8
    -0.466
    (37.1101)
    MEDD, Change at Week 12
    2.019
    (41.4507)
    MEDD, Change at Week 16
    7.404
    (20.9301)
    MEDD, Change at Week 20
    8.927
    (20.2095)
    MEDD, Change at Week 24
    4.392
    (15.0878)
    NSAID, Baseline
    60.8
    (251.32)
    NSAID, Change at Week 1
    4.1
    (126.15)
    NSAID, Change at Week 4
    -6.1
    (278.40)
    NSAID, Change at Week 8
    -6.1
    (371.14)
    NSAID, Change at Week 12
    -32.9
    (401.50)
    NSAID, Change at Week 16
    -53.8
    (342.47)
    NSAID, Change at Week 20
    -55.4
    (304.09)
    NSAID, Change at Week 24
    -68.9
    (312.55)
    7. Other Pre-specified Outcome
    Title Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24
    Description 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.
    Time Frame Baseline, Week 1, Week 4, Week 12, Week 16, Week 20, and Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable worse pain scores.
    Arm/Group Title Cryoablation
    Arm/Group Description 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.
    Measure Participants 66
    Baseline
    7.3
    (2.04)
    Change at Week 1
    -2.0
    (2.6)
    Change at Week 4
    -2.6
    (3.12)
    Change at Week 8
    -2.5
    (3.23)
    Change at Week 12
    -3.3
    (3.53)
    Change at Week 16
    -3.6
    (3.46)
    Change at Week 20
    -3.5
    (3.32)
    Change at Week 24
    -3.4
    (3.22)
    8. Other Pre-specified Outcome
    Title Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24
    Description 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.
    Time Frame Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable average pain scores.
    Arm/Group Title Cryoablation
    Arm/Group Description All participants had 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 was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
    Measure Participants 65
    Baseline
    5.6
    (1.93)
    Change at Week 1
    -1.6
    (2.49)
    Change at Week 4
    -2.1
    (2.65)
    Change at Week 8
    -1.8
    (2.66)
    Change at Week 12
    -2.6
    (2.5)
    Change at Week 16
    -2.8
    (2.73)
    Change at Week 20
    -2.4
    (2.75)
    Change at Week 24
    -2.8
    (2.48)
    9. Other Pre-specified Outcome
    Title Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
    Description 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.
    Time Frame Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable OTE data.
    Arm/Group Title Cryoablation
    Arm/Group Description All participants had 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 was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
    Measure Participants 64
    Better than the Last Visit, Week 1
    60.9
    92.3%
    Better than the Last Visit, Week 4
    58.6
    88.8%
    Better than the Last Visit, Week 8
    48.1
    72.9%
    Better than the Last Visit, Week 12
    39.0
    59.1%
    Better than the Last Visit, Week 16
    38.5
    58.3%
    Better than the Last Visit, Week 20
    27.0
    40.9%
    Better than the Last Visit, Week 24
    29.7
    45%
    Same as the Last Visit, Week 1
    26.6
    40.3%
    Same as the Last Visit, Week 4
    24.1
    36.5%
    Same as the Last Visit, Week 8
    36.5
    55.3%
    Same as the Last Visit, Week 12
    51.2
    77.6%
    Same as the Last Visit, Week 16
    48.7
    73.8%
    Same as the Last Visit, Week 20
    56.8
    86.1%
    Same as the Last Visit, Week 24
    56.8
    86.1%
    Worse than the Last Visit, Week 1
    12.5
    18.9%
    Worse than the Last Visit, Week 4
    12.1
    18.3%
    Worse than the Last Visit, Week 8
    13.5
    20.5%
    Worse than the Last Visit, Week 12
    9.8
    14.8%
    Worse than the Last Visit, Week 16
    12.8
    19.4%
    Worse than the Last Visit, Week 20
    13.5
    20.5%
    Worse than the Last Visit, Week 24
    10.8
    16.4%
    Missing, Week 1
    0
    0%
    Missing, Week 4
    5.2
    7.9%
    Missing, Week 8
    1.9
    2.9%
    Missing, Week 12
    0
    0%
    Missing, Week 16
    0
    0%
    Missing, Week 20
    2.7
    4.1%
    Missing, Week 24
    2.7
    4.1%
    10. Other Pre-specified Outcome
    Title Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects
    Description 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.
    Time Frame Baseline up to 30 days post-cryoablation

    Outcome Measure Data

    Analysis Population Description
    Participants for whom received the complete study cryoablation procedure (Safety Population).
    Arm/Group Title Cryoablation
    Arm/Group Description All participants had 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 was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
    Measure Participants 65
    Intra-operative non-serious adverse event
    3
    4.5%
    Post-operative non-serious adverse event
    3
    4.5%
    Non-serious event after discharge within 30 days
    8
    12.1%
    Serious adverse event
    3
    4.5%
    Unanticipated adverse device effect
    0
    0%

    Adverse Events

    Time Frame Up to Week 24
    Adverse Event Reporting Description All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population [N=65]).
    Arm/Group Title Cryoablation
    Arm/Group Description 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.
    All Cause Mortality
    Cryoablation
    Affected / at Risk (%) # Events
    Total 19/73 (26%)
    Serious Adverse Events
    Cryoablation
    Affected / at Risk (%) # Events
    Total 3/65 (4.6%)
    Gastrointestinal disorders
    Abdominal pain 1/65 (1.5%)
    Injury, poisoning and procedural complications
    Burn 1/65 (1.5%)
    Vascular disorders
    Hematoma 1/65 (1.5%)
    Other (Not Including Serious) Adverse Events
    Cryoablation
    Affected / at Risk (%) # Events
    Total 13/65 (20%)
    Cardiac disorders
    Pericardial Effusion 1/65 (1.5%)
    Gastrointestinal disorders
    Nausea 2/65 (3.1%)
    Vomiting 1/65 (1.5%)
    General disorders
    Fatigue 1/65 (1.5%)
    Localized Edema 1/65 (1.5%)
    Pain at needle site 1/65 (1.5%)
    Musculoskeletal and connective tissue disorders
    Back pain 1/65 (1.5%)
    Buttock pain 1/65 (1.5%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumor pain 2/65 (3.1%)
    Nervous system disorders
    Neuralgia 1/65 (1.5%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 1/65 (1.5%)
    Pleural effusion 1/65 (1.5%)
    Vascular disorders
    Hypotension 1/65 (1.5%)
    Hematoma 1/65 (1.5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Galil Medical can require Investigator to postpone publications/presentations for up to 12 months so data from all sites can be published. Galil Medical will limit review of Investigator's draft to confirm Confidential Information is not being disclosed. If Galil Medical notes publishing Study results may affect obtaining a patent, Investigator may not publish for up to 60 days until patent application is filed. Investigator will acknowledge Galil Medical in any publication/presentation.

    Results Point of Contact

    Name/Title Sr. Clinical Trial Specialist
    Organization Galil Medical, a wholly owned indirect subsidiary of Boston Scientific
    Phone 651-287-5000
    Email GalilClinical@bsci.com
    Responsible Party:
    Boston Scientific Corporation
    ClinicalTrials.gov Identifier:
    NCT02511678
    Other Study ID Numbers:
    • CGC15-BNE098
    First Posted:
    Jul 30, 2015
    Last Update Posted:
    Jul 19, 2021
    Last Verified:
    Jul 1, 2021