A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance
OBJECTIVES:
- Determine the side effects of radiofrequency ablation in patients with bone metastases.
- Determine the effect of this regimen on pain in these patients.
- Determine the effect of this regimen on mood in these patients.
- Determine the effects of narcotic usage in patients treated with this regimen.
- Determine the relationship between laboratory and imaging features of this treatment
and the effects of the treatment in these patients.
OUTLINE: This is a multicenter study.
Patients undergo percutaneous CT-guided radiofrequency ablation directly to the metastatic
lesion over approximately 12 minutes.
Pain and mood are assessed at baseline, daily for 14 days after treatment, and at 1 and 3
months after treatment.
Patients are followed at 1 week and then at 1 and 3 months.
PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study within 12.5
months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Adverse events
Yes
Damian E. Dupuy, MD
Study Chair
Rhode Island Hospital
United States: Federal Government
CDR0000069012
NCT00026247
November 2001
Name | Location |
---|---|
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
Comprehensive Cancer Center at Rhode Island Hospital | Providence, Rhode Island 02903 |
Mallinckrodt Institute of Radiology at Washington University Medical Center | St. Louis, Missouri 63110 |
Radiology Consultants, Incorporated | Youngstown, Ohio 44512 |