Percutaneous US and CT-Guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8
No
Matthew R. Callstrom, MD, PhD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000581162
NCT00608855
November 2003
Name | Location |
---|---|
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 |