Excision Followed by Radiofrequency Ablation for Breast Cancer (ABLATE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Arkansas
Sponsor:
Collaborator:
Angiodynamics, Inc.
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01153035
First received: June 24, 2010
Last updated: May 8, 2014
Last verified: May 2014
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: No ]
    How many patients must go back for re-excision of margins

  • Decrease local recurrence [ Time Frame: Monitor throughout 5 year follow-up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Assess cosmesis and quality of life (QOL) [ Time Frame: Assess throughout 5 year follow-up ] [ Designated as safety issue: No ]
  • Monitor side effects and complications [ Time Frame: Monitor immediately after surgery (beginning in the OR and continuing throughout 5 year follow-up ] [ Designated as safety issue: No ]
  • Monitor the peri-cavitary zone of eRFA-induced Doppler enhancement [ Time Frame: Intra-operative assessment (defined as the period of time, usually around 15 minutes, that the surgeon is performing the RFA while in the OR suite) ] [ Designated as safety issue: No ]
  • Monitor treatment related effects on post-operative imaging [ Time Frame: Monitor throughout 5 year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: June 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   50 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153035

Contacts
Contact: Laura Adkins, MAP, CCRP 501-526-6990 ext 8268 lladkins@uams.edu
Contact: Maureen McCarthy, RNP 501-526-6990 ext 8265 mamccarthy@uams.edu

Locations
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85704
Contact: Monica Delbridge    520-694-2873      
Principal Investigator: Rebecca Viscusi, MD         
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Adkins       lladkins@uams.edu   
Contact: McCarthy       mamccarthy@uams.edu   
Principal Investigator: Suzanne Klimberg, MD         
United States, California
Sharp Oncology (Comprehensive Breast Care of San Diego) Recruiting
San Diego, California, United States, 92123
Contact: Lisa Obregon, RN, BSN, OCN    858-939-5052      
Principal Investigator: Robert Barone, DO         
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: Amiya Vaz    212-305-1317      
Principal Investigator: Sheldon Marc Feldman, MD         
Sponsors and Collaborators
University of Arkansas
Angiodynamics, Inc.
Investigators
Principal Investigator: Suzanne Klimberg, MD University of Arkansas
  More Information

Publications:
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01153035     History of Changes
Obsolete Identifiers: NCT01420380
Other Study ID Numbers: 104603
Study First Received: June 24, 2010
Last Updated: May 8, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014