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Percutaneous Removal and Margin Ablation for Breast Cancer

NCT00574301 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-07-25

No results posted yet for this study

Summary

We hypothesize that radiofrequency ablation after single-insertion image guided vacuum assisted biopsy (IVEB) can be used to achieve negative margins in small unicentric breast cancers (≤1.5 cm).

Conditions

Interventions

PROCEDURE

Percutaneous Removal and Margin Ablation

Patients with a diagnosis of unicentric invasive breast cancer diagnosed by IVEB will then be assigned to the next available surgery date. On that day, the patient's axillary staging will be done, followed by ablation of the biopsy cavity using RFA. The breast surgery may include lumpectomy (which will be directed with US-guidance to assure more accurate removal of the en bloc IVEB site and the margin zone of ablation) or simple mastectomy with or without reconstruction. The tissue specimen will be sent immediately from the operating room to Pathology for routine processing.

Sponsors & Collaborators

Principal Investigators

  • V. Suzanne Klimberg, MD · University of Arkansas

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2007-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00574301 on ClinicalTrials.gov