Percutaneous US and CT-guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study

Brief Summary

Detailed Description

OBJECTIVES: * To confirm the safety of percutaneous cryoablation in the palliative treatment of patients with painful bone metastases. * To determine the benefits of cryoablation of painful bone metastases by assessing pain intensity using a standardized Cleeland Brief Pain Inventory (BPI) and quality of life using a standardized SF-8 both before and after treatment. * To determine the secondary benefits of cryoablation of painful bone metastases by assessing change in analgesic use following therapy. * To determine the level of anesthesia required for cryoablation with a baseline level of conscious sedation planned for each treatment. OUTLINE: This is a multicenter study. Patients undergo percutaneous cryoablation to one or two sites of metastatic disease using the Endocare Cryocare system. Patients with a good initial response to treatment (≥ 2 decrease in pain intensity rating on the Brief Pain Inventory) who develop recurrent pain at the same site or a new painful site ≥ 1 month after initial treatment may undergo one additional cryoablation treatment. Patients complete pain and quality of life questionnaires periodically. After completion of study treatment, patients are followed periodically for 2 years.

Primary Outcomes

Secondary Outcomes

• Average difference in pre- and post-treatment worst pain score in a 24-hour period, average pain score, and pain relief score at 6, 12, and 24 months
• Average amount of pain per patient over the observation period as represented by the area under the curve (AUC) constructed from weekly pain scores on a visual-analogue scale using a score of 0-10
• Percentage of patients who are able to reduce analgesic medications