Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases
NCT ID: NCT02511678
Last Updated: 2021-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2016-02-15
2018-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Cryoablation
The application of repeated freeze and thaw cycles to the identified tissues.
Interventions
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Cryoablation
The application of repeated freeze and thaw cycles to the identified tissues.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jack Jennings, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University Saint Louis
Locations
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UCLA Ronald Reagan Medical Center
Los Angeles, California, United States
Emory University Hospital
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Crittenton Hospital
Rochester, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Institut Bergonié
Bordeaux, , France
Centre Léon Bérard
Lyon, , France
University Hospital of Strasbourg
Strasbourg, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CGC15-BNE098
Identifier Type: -
Identifier Source: org_study_id
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