Excision Followed by Radiofrequency Ablation for Breast Cancer

Description

The purpose of this study will be to evaluate, in a multi-center setting, the ability of radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the "final" negative margin and consequently decrease the rates of re-operation. During the initial breast conservation procedure (lumpectomy), immediately following routine surgical resection of the tumor, radiofrequency energy (RFA) is applied to the wall (bed) of the fresh lumpectomy cavity, thus extending tumor free margin radially beyond the volume of the resected specimen.

Study Start Date

June 2010

Estimated Completion Date

June 2020

Interventions

  • Device: Radiofrequency Ablation

Specialties

  • Obstetrics & Gynecology: Breast
  • Oncology: Breast,Pharmacology/Therapy
  • Radiology: Radiotherapy (XRT)
  • Physician Assistant: Hematology/Oncology,Radiology

MeSH Terms

  • Breast Neoplasms
  • Radiofrequency Ablation

Study ID

University of Arkansas -- 104603

Status

Unknown

Trial ID

NCT01153035

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

300

Sponsor

University of Arkansas

Inclusion Criteria

  • Patient is a female, >= 50 years of age
  • The tumor size is <= 3 cm (on pre-study radiologic OR clinical exam)
  • The tumor is unicentric and unilateral
  • The tumor is not involving the skin
  • Pathology confirms ductal in situ (DCIS) OR infiltrating ductal carcinoma (IDC), grade I-III
  • If tumor is IDC, pathology must be hormone receptor positive (ER+ and/or PR+)
  • Patient signs current written informed consent and HIPAA forms

Exclusion Criteria

  • Patient is under 50 years of age
  • Patient is male
  • Tumor > 3 cm in diameter
  • Bilateral malignancy
  • Clinically positive lymph nodes
  • Tumor involving the skin
  • Pathology confirms invasive lobular carcinoma
  • Breast implants
  • Less than 2 years disease-free survival from previous breast cancer
  • Neoadjuvant chemotherapy or chemotherapy for another breast cancer within two years

Gender

Female

Ages

50 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (8)

Study Location Distance Name Phone Email
Columbia - New York, New York 44.8 miles None None None
Columbia - New York, New York 44.8 miles Catherine Baker CRC 212-305-6679 None
University of Arkansas for Medical Sciences - Little Rock, Arkansas 1,131.5 miles None None None
The University of Kansas Cancer Center - Westwood, Kansas 1,139.7 miles Stella Baccaray RN None None
The University of Kansas Cancer Center - Westwood, Kansas 1,139.7 miles None None None
Comprehensive Breast Care of Denver - Denver, Colorado 1,665.3 miles None None None
University of Arizona - Tucson, Arizona 2,163.8 miles None None None
Sharp Oncology Comprehensive Breast Care of San Diego - San Diego, California 2,469.3 miles None None None

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