Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026247
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2001-11-09
Brief Title:
Radiofrequency Ablation in Treating Patients With Bone Metastases
Sponsor:
American College of Radiology Imaging Network
Organization:
American College of Radiology Imaging Network
Study Overview
Official Title:
A Phase III Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACRIN-6661
Brief Summary:
RATIONALE Radiofrequency ablation may be effective in decreasing pain from bone metastases
PURPOSE Phase III trial to study the effectiveness of radiofrequency ablation in decreasing pain in patients who have bone metastases
PURPOSE Phase III 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 125 months
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 125 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA079778 | NIH | CIP | httpsreporternihgovquickSearchU01CA079778 |
| ACRIN-6661 | OTHER | None | None |
| U01CA080098 | NIH | None | None |