Radiofrequency Ablation in Treating Patients With Early Invasive Breast Cancer or Ductal Carcinoma in Situ
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|ClinicalTrials.gov Identifier: NCT00388115|
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : March 29, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiofrequency ablation||Not Applicable|
- 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.
- 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 RFA/resection 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Radiofrequency Ablation of Early Invasive and In Situ Breast Cancer|
|Study Start Date :||October 2001|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
|Experimental: RFA prior to surgery||
Procedure: conventional surgery
Standard of care lumpectomy or mastectomy following RFAProcedure: neoadjuvant therapy
Standard of care lumpectomy or mastectomy following RFAProcedure: radiofrequency ablation
A small diameter needle is inserted through the skin and directly into the tumor for the purpose of supplying RF current. Initial power of the RF generator will start at 5-10 watts. The power will increase by 5-10 watts every minute until impedance of the system automatically stops the RF treatment.
Other Name: RFA
- Number and proportion of patients with viable cancer cells remaining in the resected specimen as measured by enzyme cell viability analysis and amount of tumor coagulated at post-treatment biopsy [ Time Frame: At completion of study ]
- Number and proportion of patients with uncoagulated tumor remnant at post-treatment biopsy [ Time Frame: At completion of study ]
- Number and proportion of patients with and without tumor in the margin [ Time Frame: At completion of study ]
- Rate of acute skin toxicity [ Time Frame: At completion of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388115
|United States, California|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Vijay Khatri, MD||University of California, Davis|