Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

Conditions
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Pain, Neoplasm Metastasis, Bone Metastasis of Diverse Origins

Intervention / Treatment
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* Device: Cryoablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoablation<br>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<br>* The application of repeated freeze and thaw cycles to the identified tissues.<br>* Other names: IcePearl® 2.1 Cryoablation Needle;|

What is the study measuring?
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Primary Outcome Measures

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