Clinical trial NCT00574301: Percutaneous Removal and Margin Ablation for Breast Cancer
Official title: Percutaneous Removal and Margin Ablation for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: Image Guided Vacuum Assisted Biopsy
Radiofrequency Ablation
Breast Conservation Therapy
Mastectomy
MRI
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: Ethicon Endo-Surgery
name: RITA Medical Systems
First posted: 2007-12-17
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We hypothesize that radiofrequency ablation after single-insertion image guided vacuum assisted biopsy (IVEB) can be used to achieve negative margins in small unicentric breast cancers (≤1.5 cm).

Detailed description: Using the Mammotome Breast Biopsy System (IVEB) in conjunction with MRI to predict extent of disease, ultrasound to direct removal of the tumor, touch preparation cytology for diagnosis, and ablation of margins using radiofrequency ablation (RFA), we propose to develop a comprehensive system for same-day diagnosis and treatment of patients with small breast lesions.

Eligibility criteria: Inclusion Criteria:

* Female, 18 to 90 years of age
* Non-pregnant, not breastfeeding
* Pre-study documentation of:
* Size ≤1.5 cm cancer successfully removed by US-guided IVEB within 30 days of registration
* Uni-centricity, unilateral cancer by radiology (mammogram and MRI)
* Location of abnormality \> 1 cm from the skin
* Ductal Carcinoma, Invasive (Grade I-III) or In-Situ
* No palpable axillary or supraclavicular lymph nodes
* Good general health
* Zubrod Performance Status of 0, 1, or 2
* If prior non-breast malignancy, must have 5 year disease-free survival
* No prior chemotherapy
* Hormonal therapy must be stopped
* Therapy with tamoxifen must have been of 14 days or less duration

Exclusion Criteria:

* Subjects less than 18 years of age or greater than 90 years of age
* Pregnant or breastfeeding
* Male
* Prior Breast Biopsy affected breast
* Breast implants
* Multicentric disease, bilateral disease
* Residual disease after IVEB of \> 1cm on MRI
* Lesions \> 1.5 cm in diameter
* Lesions \< 1 cm from skin surface
* Previous radiation therapy to the breast

Primary outcomes:
measure: To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation
timeFrame: Post-surgical pathology review
Secondary outcomes:
measure: The proportion of patients with viable tumor cells beyond the margin
timeFrame: Post-surgical pathology review
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas For Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: V. Suzanne Klimberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson AT, Henry-Tillman RS, Smith LF, Harshfield D, Korourian S, Brown H, Lane S, Colvert M, Klimberg VS. Percutaneous excisional breast biopsy. Am J Surg. 2002 Dec;184(6):550-4; discussion 554. doi: 10.1016/s0002-9610(02)01099-1.
citation: Klimberg VS, Boneti C, Adkins LL, Smith M, Siegel E, Zharov V, Ferguson S, Henry-Tillman R, Badgwell B, Korourian S. Feasibility of percutaneous excision followed by ablation for local control in breast cancer. Ann Surg Oncol. 2011 Oct;18(11):3079-87. doi: 10.1245/s10434-011-2002-y. Epub 2011 Sep 9.