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

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Galil Medical
Sponsor:
Information provided by (Responsible Party):
Galil Medical
ClinicalTrials.gov Identifier:
NCT02511678
First received: July 27, 2015
Last updated: March 6, 2017
Last verified: March 2017
  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


Estimated Enrollment: 60
Study Start Date: February 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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02511678

Contacts
Contact: Joy Benson, BA 651-287-5112 joy.benson@galilmedical.com

Locations
United States, California
UCLA Ronald Reagan Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Barbara Lee    310-794-8048    BarbaraLee@mednet.ucla.edu   
Principal Investigator: Scott Genshaft, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Maria V Rivas    404-712-7962    mrivas2@emory.edu   
Contact: John D Prologo, MD    404-712-7033    john.david.prologo@emory.edu   
Principal Investigator: John D Prologo, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Erin Elias    617-643-0244    eelias@partners.org   
Principal Investigator: Ambrose J Huang, MD         
United States, Michigan
Crittenton Hospital Recruiting
Rochester, Michigan, United States, 48307
Principal Investigator: Peter Littrup, MD         
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Connie Sathre    507-538-0540    Sathre@mayo.edu   
Principal Investigator: Anil Kurup, MD         
Sub-Investigator: Matthew Callstrom, MD, PhD         
Sub-Investigator: David Woodrum, MD, PhD         
Sub-Investigator: Thomas Atwell, MD         
Sub-Investigator: Grant Schmidt, MD         
Sub-Investigator: Adam Weisbrod, MD         
Sub-Investigator: John Schmitz, MD         
Sub-Investigator: Patrick Eiken, MD         
United States, Missouri
Washington University in St. Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Robin Haverman    314-747-1624    havermanr@wustl.edu   
Principal Investigator: Jack Jennings, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Elizabeth (Liz) Morrell    401-444-2277    emorrell@lifespan.org   
Contact: Wendy Smith    401-444-4233    wsmith@lifespan.org   
Principal Investigator: Jason Iannuccilli, MD         
Sub-Investigator: Damian Depuy, MD         
France
Institut Bergonié Recruiting
Bordeaux, France, 33000
Contact: Laurence Virmoux    +33 556 33 33 33    L.Virmoux@bordeaux.unicancer.fr   
Principal Investigator: Xavier Buy, MD         
Sub-Investigator: Jean Palussière, MD         
Sub-Investigator: Vittorio Catena, MD         
Centre Léon Bérard Recruiting
Lyon, France, 69373
Contact: Nathalie Bellone    Office: +33 (0)4 26 55 67 41    nathalie.bellone@lyon.unicancer.fr   
Principal Investigator: Frank Pilleul, MD PhD         
Sub-Investigator: Charles Mastier, MD         
Sub-Investigator: Amine Bouhamama, MD         
Sub-Investigator: Marie Cuinet, MD         
University Hospital of Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Abdelaziz Tarif    +33 03.69 .55.15 .71    abdelaziz.tarif@chru-strasbourg.fr   
Principal Investigator: Julien Garnon, MD         
Sub-Investigator: Afshin Gangi, MD PhD         
Sub-Investigator: Georgia Tsoumakidou, MD         
Sub-Investigator: Jean Caudrelier, MD         
Sub-Investigator: Roberto Luigi Cazzato, MD         
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Coralie Gasc    +33 1 52 11 54 09    coralie.gasc@gustaveroussy.fr   
Principal Investigator: Frédéric Deschamps, MD         
Sub-Investigator: Lambros Tselikas, MD         
Sub-Investigator: Bakar Ba, MD         
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
Study First Received: July 27, 2015
Last Updated: March 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on August 18, 2017