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Excision Followed by Radiofrequency Ablation for Breast Cancer (ABLATE)

This study is currently recruiting participants.
Verified August 2017 by University of Arkansas
Sponsor:
ClinicalTrials.gov Identifier:
NCT01153035
First Posted: June 29, 2010
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Angiodynamics, Inc.
Information provided by (Responsible Party):
University of Arkansas
  Purpose
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.

Condition Intervention
Breast Cancer Device: Radiofrequency Ablation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Estimate the re-excision rate for close (<3mm) or positive margins [ Time Frame: Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed) ]
    How many patients must go back for re-excision of margins

  • Decrease local recurrence [ Time Frame: Monitor throughout 5 year follow-up ]
    The patient will be followed closely from the time of surgery through a period of 5 years in order to assess the frequency of local recurrence, defined as a new diagnosis of cancer at or near the site of primary surgery. It is our thought that the addition of RFA to the standard surgical treatment will reduce the number of local recurrences.


Estimated Enrollment: 300
Study Start Date: June 2010
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Surgery followed by RFA Device: Radiofrequency Ablation
Breast conservation surgery followed by Radiofrequency Ablation of the cavity
Other Name: AngioDynamics, Inc.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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-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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153035


Contacts
Contact: Beth Scanlan 5015266245 bscanlan@uams.edu

Locations
United States, Arizona
University of Arizona Active, not recruiting
Tucson, Arizona, United States, 85704
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Beth Scanlan       bscanlan@uams.edu   
Principal Investigator: Daniela Ochoa, MD         
United States, California
Sharp Oncology (Comprehensive Breast Care of San Diego) Active, not recruiting
San Diego, California, United States, 92123
United States, Colorado
Comprehensive Breast Care of Denver Recruiting
Denver, Colorado, United States, 80218
Contact: Nancy Weber, RN, CCRP    303-318-2271    Nancy.Weber@sclhs.net   
Contact: Julie Barone, DO    303.318.3413      
Principal Investigator: Julie Barone, DO, FACS         
United States, Kansas
The University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Stella Baccaray, RN         
Principal Investigator: Marilee McGinness, MD         
United States, New York
Columbia Recruiting
New York, New York, United States, 10032
Contact: Catherine Baker, CRC    212-305-6679      
Principal Investigator: Sheldon Marc Feldman, MD         
Sponsors and Collaborators
University of Arkansas
Angiodynamics, Inc.
Investigators
Principal Investigator: Daniela Ochoa, MD University of Arkansas
  More Information