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Excision Followed by Radiofrequency Ablation for Breast Cancer (ABLATE)

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ClinicalTrials.gov Identifier: NCT01153035
Recruitment Status : Recruiting
First Posted : June 29, 2010
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
Angiodynamics, Inc.
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Device: Radiofrequency Ablation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Study Start Date : June 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Surgery followed by RFA Device: Radiofrequency Ablation
Breast conservation surgery followed by Radiofrequency Ablation of the cavity
Other Name: AngioDynamics, Inc.



Primary Outcome Measures :
  1. 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

  2. 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.



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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

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

Publications of Results:
Other Publications:
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01153035     History of Changes
Obsolete Identifiers: NCT01420380
Other Study ID Numbers: 104603
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Keywords provided by University of Arkansas:
Breast Conservation Therapy
Lumpectomy
Radiofrequency Ablation
Radiation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases