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

Not Applicable

Withdrawn

• Conditions: Breast Cancer
• Interventions: Device: RFA Applicator

• Registration Number: NCT02525913
• Lead Sponsor: University of Arkansas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-18
• Study Start: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-12
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bi-lateral mastectomy	RFA Applicator	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States