NCT00026247

Radiofrequency Ablation in Treating Patients With Bone Metastases

A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: American College of Radiology Imaging Network · Network
• Sex: All
• Age: 21 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiofrequency ablation may be effective in decreasing pain from bone metastases. PURPOSE: Phase I/II trial to study the effectiveness of radiofrequency ablation in decreasing pain in patients who have bone metastases.

Detailed description

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.

Conditions

• Metastatic Cancer
• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
PROCEDURE	pain therapy
PROCEDURE	radiofrequency ablation

Timeline

• Start date: 2001-11-01
• Primary completion: 2010-02-15
• Completion: 2010-02-15
• First posted: 2003-01-27
• Last updated: 2019-07-05

Locations

8 sites across 1 country: United States