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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02525913
• Other study ID #: 204538
• Status: Withdrawn
• Phase: N/A
• First received: August 13, 2015
• Last updated: October 7, 2015
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2015
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• RFA Applicator

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Innoblative Designs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year	No