Pain Clinical Trial
Official title:
Percutaneous US and CT-guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study
RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases.
PURPOSE: This clinical trial is studying the side effects and how well percutaneous
cryoablation works in treating patients with painful bone metastases.
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.
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Masking: Open Label, Primary Purpose: Treatment
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