Breast Cancer
Conditions
Keywords
Breast Conservation Therapy, Lumpectomy, Radiofrequency Ablation, Radiation
Brief summary
The purpose of this study will be to evaluate, in a multi-center setting, the ability of radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the final negative margin and consequently decrease the rates of re-operation. During the initial breast conservation procedure (lumpectomy), immediately following routine surgical resection of the tumor, radiofrequency energy (RFA) is applied to the wall (bed) of the fresh lumpectomy cavity, thus extending tumor free margin radially beyond the volume of the resected specimen.
Interventions
DEVICERadiofrequency Ablation
Breast conservation surgery followed by Radiofrequency Ablation of the cavity
Sponsors
Angiodynamics, Inc.
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patient is a female, ≥ 50 years of age * The tumor size is ≤ 3 cm (on pre-study radiologic OR clinical exam) * The tumor is unicentric and unilateral * The tumor is not involving the skin * Pathology confirms ductal in situ (DCIS) OR infiltrating ductal carcinoma (IDC), grade I-III * If tumor is IDC, pathology must be hormone receptor positive (ER+ and/or PR+) * Patient signs current written informed consent and HIPAA forms
Exclusion criteria
* Patient is under 50 years of age * Patient is male * Tumor \> 3 cm in diameter * Bilateral malignancy * Clinically positive lymph nodes * Tumor involving the skin * Pathology confirms invasive lobular carcinoma * Breast implants * Less than 2 years disease-free survival from previous breast cancer * Neoadjuvant chemotherapy or chemotherapy for another breast cancer within two years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimate the re-excision rate for close (<3mm) or positive margins | Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed) | How many patients must go back for re-excision of margins |
| Decrease local recurrence | Monitor throughout 5 year follow-up | The patient will be followed closely from the time of surgery through a period of 5 years in order to assess the frequency of local recurrence, defined as a new diagnosis of cancer at or near the site of primary surgery. It is our thought that the addition of RFA to the standard surgical treatment will reduce the number of local recurrences. |
Countries
United States
Outcome results
None listed