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

Withdrawn before enrolling · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02525913

Run by

University of Arkansas

People needed

0

Starts

2015-09-01

Expected to finish

2016-09-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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