Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00388115
Status:
COMPLETED
Last Update Posted:
2010-03-29
First Post:
2006-10-12
Brief Title:
Radiofrequency Ablation in Treating Patients With Early Invasive Breast Cancer or Ductal Carcinoma in Situ
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
A Pilot Study of Radiofrequency Ablation of Early Invasive and In Situ Breast Cancer
Status:
COMPLETED
Status Verified Date:
2010-03
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 a high-frequency electric current to kill tumor cells Giving radiofrequency ablation before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This clinical trial is studying how well radiofrequency ablation followed by surgery works in treating patients with early invasive breast cancer or ductal carcinoma in situ
PURPOSE This clinical trial is studying how well radiofrequency ablation followed by surgery works in treating patients with early invasive breast cancer or ductal carcinoma in situ
Detailed Description:
OBJECTIVES
Primary
Determine the effectiveness of radiofrequency ablation RFA in terms of amount of tumor coagulated and viable cell count in patients with early invasive breast cancer or low- or intermediate-grade ductal carcinoma in situ
Secondary
Determine the size configuration and pathological features of human breast tumors after treatment with RFA
Determine whether RFA energy applied to breast cancer will result in cancer cell death
Determine whether tumor-free margins are achieved by RFA in these patients
Determine the rate of acute toxicities to skin after surgery in patients treated with this regimen
OUTLINE This is a pilot study
Pre-radiofrequency ablation RFA procedures Patients undergo staging by MRI assessment to determine the size of their tumor Patients with nonpalpable lesions must undergo placement of a metallic clip in the center of their tumor and a hook wire to guide surgical excision by intraoperative ultrasound imaging Patients with invasive breast cancer undergo axillary lymph node dissection or sentinel lymph node biopsy SLNB for axillary lymph node staging Patients with ductal carcinoma in situ proceed directly to RFAresection since they do not require axillary staging
RFA Patients undergo RFA comprising insertion of a multiple-needle electrode into the breast tumor under direct guidance of ultrasonography and the metallic clip placed preoperatively in the lesion
Surgical resection of RFA area After RFA is completed the electrode is removed and patients undergo wide local excision of the residual tumor or mastectomy
After completion of study therapy patients are followed periodically for up to 4 months
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the effectiveness of radiofrequency ablation RFA in terms of amount of tumor coagulated and viable cell count in patients with early invasive breast cancer or low- or intermediate-grade ductal carcinoma in situ
Secondary
Determine the size configuration and pathological features of human breast tumors after treatment with RFA
Determine whether RFA energy applied to breast cancer will result in cancer cell death
Determine whether tumor-free margins are achieved by RFA in these patients
Determine the rate of acute toxicities to skin after surgery in patients treated with this regimen
OUTLINE This is a pilot study
Pre-radiofrequency ablation RFA procedures Patients undergo staging by MRI assessment to determine the size of their tumor Patients with nonpalpable lesions must undergo placement of a metallic clip in the center of their tumor and a hook wire to guide surgical excision by intraoperative ultrasound imaging Patients with invasive breast cancer undergo axillary lymph node dissection or sentinel lymph node biopsy SLNB for axillary lymph node staging Patients with ductal carcinoma in situ proceed directly to RFAresection since they do not require axillary staging
RFA Patients undergo RFA comprising insertion of a multiple-needle electrode into the breast tumor under direct guidance of ultrasonography and the metallic clip placed preoperatively in the lesion
Surgical resection of RFA area After RFA is completed the electrode is removed and patients undergo wide local excision of the residual tumor or mastectomy
After completion of study therapy patients are followed periodically for up to 4 months
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA093373 | NIH | None | None |
| UCD-123 | OTHER | None | None |
| UCD-200210277-6 | OTHER | University of California Davis - IRB | httpsreporternihgovquickSearchP30CA093373 |