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Percutaneous Removal and Margin Ablation for Breast Cancer


Phase 1/Phase 2
18 Years
90 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Percutaneous Removal and Margin Ablation for Breast Cancer


Using the Mammotome Breast Biopsy System (IVEB) in conjunction with MRI to predict extent of
disease, ultrasound to direct removal of the tumor, touch preparation cytology for
diagnosis, and ablation of margins using radiofrequency ablation (RFA), we propose to
develop a comprehensive system for same-day diagnosis and treatment of patients with small
breast lesions.


Inclusion Criteria:



- Female, 18 to 90 years of age

- Non-pregnant, not breastfeeding

- Pre-study documentation of:

- Size ≤1.5 cm cancer successfully removed by US-guided IVEB within 30 days of
registration

- Uni-centricity, unilateral cancer by radiology (mammogram and MRI)

- Location of abnormality > 1 cm from the skin

- Ductal Carcinoma, Invasive (Grade I-III) or In-Situ

- No palpable axillary or supraclavicular lymph nodes

- Good general health

- Zubrod Performance Status of 0, 1, or 2

- If prior non-breast malignancy, must have 5 year disease-free survival

- No prior chemotherapy

- Hormonal therapy must be stopped

- Therapy with tamoxifen must have been of 14 days or less duration

Exclusion Criteria:

- Subjects less than 18 years of age or greater than 90 years of age

- Pregnant or breastfeeding

- Male

- Prior Breast Biopsy affected breast

- Breast implants

- Multicentric disease, bilateral disease

- Residual disease after IVEB of > 1cm on MRI

- Lesions > 1.5 cm in diameter

- Lesions < 1 cm from skin surface

- Previous radiation therapy to the breast

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation

Outcome Time Frame:

Post-surgical pathology review

Safety Issue:

No

Principal Investigator

V. Suzanne Klimberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Institutional Review Board

Study ID:

UAMS 07050

NCT ID:

NCT00574301

Start Date:

March 2002

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Image Guided Vacuum Assisted Biopsy
  • Radiofrequency Ablation
  • Breast Conservation Therapy
  • Mastectomy
  • MRI
  • Breast Neoplasms

Name

Location

University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205