Feasibility Study of Cavity Radiofrequency Ablation in ex Vivo Mastectomy Breast Tissue

University of Arkansas

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Breast Cancer

Interventions

RFA ApplicatorDEVICE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Ablation Depth

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.

Time frame: One year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.