Kansas City, Kansas 66160

  • Breast Cancer

Purpose:

The main purpose of the study is to study the effectiveness of using a technique called RadioFrequency Ablation (RFA) after the breast tumor has been surgically removed. Ablation means cells are destroyed. The RFA device creates heat that destroys any cells in the area around where the tumor is removed, an area called the cavity or tumor bed


Study summary:

This study will evaluate 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 and potentially obviate the need for XRT in early breast cancer. 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.


Criteria:

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-II - 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


NCT ID:

NCT01420380


Primary Contact:

Principal Investigator
Marilee K McGinness, MD, FACS
University of Kansas

Marilee K McGinness, MD, FACS
Phone: 913-588-5166
Email: mmcginness@kumc.edu


Backup Contact:

Email: jmammen2@kumc.edu
Joshua Mammen, MD
Phone: 913-588-0022


Location Contact:

Kansas City, Kansas 66160
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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