Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00029029
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2002-01-04
Brief Title:
Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
RF Ablation of Painful Metastases Involving Bone
Status:
COMPLETED
Status Verified Date:
2020-08
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:
None
Brief Summary:
RATIONALE Radiofrequency ablation uses high-frequency electric current to kill tumor cells and may help to relieve pain caused by bone metastases
PURPOSE Phase II trial to study the effectiveness of radiofrequency ablation in relieving pain in patients who have bone metastases
PURPOSE Phase II trial to study the effectiveness of radiofrequency ablation in relieving pain in patients who have bone metastases
Detailed Description:
OBJECTIVES
Determine the efficacy of radiofrequency ablation in terms of pain relief at 4 weeks in patients with painful bone metastases
Determine the safety of this regimen in these patients
Compare the change in pain interference with daily life and analgesic use at 4 weeks vs baseline in patients treated with this regimen
Determine the time to recurrence of worst pain in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive radiofrequency ablation RFA to targeted tumors on day 0 multiple tumors may receive ablation in multiple sessions Patients who achieve a reduction in worst pain of at least 2 points within 4-8 weeks but experience recurring pain at the RFA site or are diagnosed with a new painful lesion within 4-24 weeks receive 1 additional treatment to the recurring or new site
Pain using the Brief Pain Inventory scale of 0-10 analgesic use and quality of life are assessed at baseline on day 1 weekly for 4 weeks and then every 2 weeks for 20 weeks
Patients are followed for 6 months beyond the last RFA treatment
PROJECTED ACCRUAL A maximum of 50 patients will be accrued for this study
Determine the efficacy of radiofrequency ablation in terms of pain relief at 4 weeks in patients with painful bone metastases
Determine the safety of this regimen in these patients
Compare the change in pain interference with daily life and analgesic use at 4 weeks vs baseline in patients treated with this regimen
Determine the time to recurrence of worst pain in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive radiofrequency ablation RFA to targeted tumors on day 0 multiple tumors may receive ablation in multiple sessions Patients who achieve a reduction in worst pain of at least 2 points within 4-8 weeks but experience recurring pain at the RFA site or are diagnosed with a new painful lesion within 4-24 weeks receive 1 additional treatment to the recurring or new site
Pain using the Brief Pain Inventory scale of 0-10 analgesic use and quality of life are assessed at baseline on day 1 weekly for 4 weeks and then every 2 weeks for 20 weeks
Patients are followed for 6 months beyond the last RFA treatment
PROJECTED ACCRUAL A maximum of 50 patients will be accrued for this study
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RITA-IDE-G000177 | None | None | None |
| RITA-201-00 | None | None | None |
| MAYO-IRB-O-1223-00 | None | None | None |
| MDA-ID-01534 | None | None | None |