Excision Followed by Radiofrequency Ablation for Breast Cancer (ABLATE)

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

June 24, 2010
June 29, 2010
January 31, 2018
June 2010
December 2019   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01153035 on Archive Site
Not Provided
  • Assess cosmesis and quality of life (QOL) [ Time Frame: Assess throughout 5 year follow-up ]
  • Monitor side effects and complications [ Time Frame: Monitor immediately after surgery (beginning in the OR and continuing throughout 5 year follow-up ]
  • 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) ]
  • Monitor treatment related effects on post-operative imaging [ Time Frame: Monitor throughout 5 year follow-up ]
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Excision Followed by Radiofrequency Ablation for Breast Cancer
ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer
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.
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Device: Radiofrequency Ablation
Breast conservation surgery followed by Radiofrequency Ablation of the cavity
Other Name: AngioDynamics, Inc.
Surgery followed by RFA
Intervention: Device: Radiofrequency Ablation

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2020
December 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
50 Years to 100 Years   (Adult, Senior)
Contact: Beth Scanlan 5015266245
United States
Not Provided
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University of Arkansas
University of Arkansas
Angiodynamics, Inc.
Principal Investigator: Daniela Ochoa, MD University of Arkansas
University of Arkansas
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP