Safety and Efficacy of Cryoablation for the Palliation of Painful Bone Metastases

Inclusion Criteria

• •18 years of age or older
• •Metastatic bone disease with metastatic disease previously confirmed by prior biopsy; or Metastatic bone disease previously confirmed on imaging \[e.g. computed tomography (CT) or magnetic resonance imaging (MRI)\] with known (biopsied) primary disease (primary bone cancer is excluded)
• •Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
• •Unremitting pain that resulted in a return visit to the oncologist. 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) despite pharmaceutical pain management
• •Pain must be from one or two painful metastatic sites in the bone that is amenable to cryoablation with CT or MRI (additional less painful metastatic sites may be present)
• •Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, MRI, or ultrasound (US) imaging
• •Tumors must be suitable for cryoablation
• •Cryoablation should be performed within 14 days of baseline evaluations
• •Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)
• •Stable use of pain medications (no changes within 2 weeks prior to the cryoablation procedure)
• •ECOG (Eastern Cooperative Oncology Group) scale performance status 0-3
• •Life expectancy ≥ 2 months
• •Platelet count \>50,000/mm³ within 6 weeks screening
• •INR (International Normalized Ratio) \<1.5 within 6 weeks screening
• •No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
• •If taking antiplatelet or anticoagulation medication, it must be able to be discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin, ibuprofen, low molecular weight heparin preparations)
• •Clinically suitable for cryoablation therapy