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

NCT02525913 | Withdrawn

• 1 other identifier: 204538
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast; Mastectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Bi-lateral mastectomy

OTHER

Device: RFA Applicator

Interventions

RFA Applicator DEVICE

Bi-lateral mastectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Arkansas: lead
• Innoblative Designs, Inc.: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Suzanne Klimberg, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 18, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

US (1)