Percutaneous US and CT-Guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study
- 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.
Masking: Open Label, Primary Purpose: Treatment
Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8
Matthew R. Callstrom, MD, PhD
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center||Madison, Wisconsin 53792-6164|
|Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center||Milwaukee, Wisconsin 53201-2901|
|NYU Cancer Institute at New York University Medical Center||New York, New York 10016|
|Brown University School of Medicine||Providence, Rhode Island 02905|