Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373152
Status:
WITHDRAWN
Last Update Posted:
2017-12-05
First Post:
2006-09-06
Brief Title:
MRI in Predicting Tumor Reponse After Radiofrequency Ablation in Women With Invasive Breast Cancer
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Breast MRI Assessment of Tumor Viability After Radiofrequency Ablation RFA
Status:
WITHDRAWN
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patient accrual
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 a high-frequency electric current to kill tumor cells Diagnostic procedures such as magnetic resonance imaging MRI may help in learning how well radiofrequency ablation works to kill breast cancer cells and help doctors predict whether breast cancer cells remain after treatment
PURPOSE This phase II trial is studying how well MRI works in predicting tumor response after radiofrequency ablation in women with invasive breast cancer
PURPOSE This phase II trial is studying how well MRI works in predicting tumor response after radiofrequency ablation in women with invasive breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine if radiofrequency ablation RFA can induce complete tumor necrosis in women with invasive breast cancer
Secondary
Determine whether breast MRI can accurately predict residual cancer and tumor necrosis in patients treated with RFA
Determine the toxicity of RFA in these patients
Determine the cosmetic outcome after RFA in these patients
OUTLINE This is a prospective nonrandomized study
Patients undergo dynamic contrast-enhanced MRI DCE-MRI using gadopentetate dimeglumine Within the next few days patients undergo radiofrequency ablation RFA over approximately 20-30 minutes Patients then undergo a second DCE-MRI 3 to 21 days after RFA followed by definitive surgery standard mastectomy or lumpectomy
Pathologic confirmation of the post-ablation DCE-MRI findings is performed within 1 to 21 days after the second MRI Tumor cell viability and proliferative activity are assessed by immunohistochemical and biomarker analysis
Primary
Determine if radiofrequency ablation RFA can induce complete tumor necrosis in women with invasive breast cancer
Secondary
Determine whether breast MRI can accurately predict residual cancer and tumor necrosis in patients treated with RFA
Determine the toxicity of RFA in these patients
Determine the cosmetic outcome after RFA in these patients
OUTLINE This is a prospective nonrandomized study
Patients undergo dynamic contrast-enhanced MRI DCE-MRI using gadopentetate dimeglumine Within the next few days patients undergo radiofrequency ablation RFA over approximately 20-30 minutes Patients then undergo a second DCE-MRI 3 to 21 days after RFA followed by definitive surgery standard mastectomy or lumpectomy
Pathologic confirmation of the post-ablation DCE-MRI findings is performed within 1 to 21 days after the second MRI Tumor cell viability and proliferative activity are assessed by immunohistochemical and biomarker analysis
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 |
|---|---|---|---|
| UMN-0412M66271 | OTHER | IRB University of Minnesota | None |