Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006255
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2000-09-11
Brief Title:
Magnetic Resonance Imaging-guided Thermal Radiofrequencey Ablation of Primary Renal Cell Carcinoma Hepatic Metastasis and Other Sites of Solid Organ Tumor and Metastases
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of Magnetic Resonance Guided and Monitored Interstitial Thermal Radiofrequency Ablation of Primary Renal Cell Carcinoma Hepatic Metastasis and Other Sites of Solid Organ Tumor and Metastases
Status:
COMPLETED
Status Verified Date:
2010-06
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 heat and kill tumor cells Magnetic resonance imaging-guided radiofrequency ablation may an effective treatment for primary kidney cancer liver metastases or other solid tumors
PURPOSE Phase II trial to study the effectiveness of magnetic-resonance-guided radiofrequency ablation in treating patients who have primary kidney cancer liver metastases or other solid tumors
PURPOSE Phase II trial to study the effectiveness of magnetic-resonance-guided radiofrequency ablation in treating patients who have primary kidney cancer liver metastases or other solid tumors
Detailed Description:
OBJECTIVES
Determine whether magnetic resonance image monitoring during radiofrequency interstitial thermal ablation can accurately predict complete destruction of focal tumor along with an adequate margin of normal tissue as demonstrated by absence of growth on subsequent imaging studies for a 1-year period in patients with primary renal cell carcinoma hepatic metastases or other solid tumors
OUTLINE Patients are stratified according to disease localized hepatic metastases vs primary renal neoplasms vs solid tumors in other sites
Patients undergo thermal ablation by radiofrequency energy under magnetic resonance guidance Thermal ablation continues until the entire tumor is treated Treatment ceases when the entire lesion has undergone necrosis or the zone of necrosis or significant heat deposition approaches vital neurovascular structures
Patients are followed at 2 weeks and at 3 6 9 and 12 months
PROJECTED ACCRUAL A total of 28-39 patients will be accrued for this study within 22-36 months
Determine whether magnetic resonance image monitoring during radiofrequency interstitial thermal ablation can accurately predict complete destruction of focal tumor along with an adequate margin of normal tissue as demonstrated by absence of growth on subsequent imaging studies for a 1-year period in patients with primary renal cell carcinoma hepatic metastases or other solid tumors
OUTLINE Patients are stratified according to disease localized hepatic metastases vs primary renal neoplasms vs solid tumors in other sites
Patients undergo thermal ablation by radiofrequency energy under magnetic resonance guidance Thermal ablation continues until the entire tumor is treated Treatment ceases when the entire lesion has undergone necrosis or the zone of necrosis or significant heat deposition approaches vital neurovascular structures
Patients are followed at 2 weeks and at 3 6 9 and 12 months
PROJECTED ACCRUAL A total of 28-39 patients will be accrued for this study within 22-36 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| NCI-G00-1850 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CWRU-2Y00 | None | None | None |