Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Excision Followed by Radiofrequency Ablation for Breast Cancer (ABLATE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University of Arkansas
Angiodynamics, Inc.
Information provided by (Responsible Party):
University of Arkansas Identifier:
First received: June 24, 2010
Last updated: November 13, 2014
Last verified: November 2014

June 24, 2010
November 13, 2014
June 2010
June 2015   (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) ] [ 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.
Same as current
Complete list of historical versions of study NCT01153035 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
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 Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
June 2015   (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
50 Years and older
Contact: Laura Adkins, MAP, CCRP 501-526-6990 ext 8268
Contact: Maureen McCarthy, RNP 501-526-6990 ext 8265
United States
Not Provided
University of Arkansas
University of Arkansas
Angiodynamics, Inc.
Principal Investigator: Suzanne Klimberg, MD University of Arkansas
University of Arkansas
November 2014

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