Breast Cancer
Conditions
Keywords
Breast, Mastectomy
Brief summary
The purpose of this study is to build a device that will consistently ablate (destroy or remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the tissue that is now irradiated after breast cancer lumpectomy. The device would be easier to handle, perform the ablation in less time and by so ablating this margin would avoid the need in many for reoperation to obtain negative margins and based on preliminary data avoid the need for radiation. This would be especially important in poor and rural patients and would lead to decreased costs of treatment in patients with favorable breast cancer.
Interventions
DEVICERFA Applicator
Sponsors
Innoblative Designs, Inc.
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * Age greater than or equal to 18 years. * Receiving bi-lateral mastectomy due to tumor in the breast, or by choice (prophylactic mastectomy). Only non-cancerous breast tissue will be included in the study. * Ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
* Those determined by the study investigator to have mental, physical, or medical conditions that would indicate that they should not participate. * Because there is no patient contact with the device no medical contraindications are foreseen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ablation Depth | One year | Ablation depth is the extent to which tissue has been completely desiccated from the wall of the cavity. It will be assessed by pathologic analysis using H&, PCNA, and Ki67 stains. The ablation depth of each slide processed is to be the smallest distance of completely necrotic tissue. |
Countries
United States
Outcome results
None listed