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ABLATE: Excision Followed by Radiofrequency Ablation for Breast Cancer

Sponsor
University of Arkansas (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01153035
Collaborator
Angiodynamics, Inc. (Industry)
104
Enrollment
6
Locations
1
Arm
162
Duration (Months)
17.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Radiofrequency Ablation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
N/A
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 :
Jun 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Surgery followed by RFA

Device: Radiofrequency Ablation
Breast conservation surgery followed by Radiofrequency Ablation of the cavity
Other Names:
  • AngioDynamics, Inc.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Estimate the re-excision rate for close (<3mm) or positive margins [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 100 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Arizona Tucson Arizona United States 85704
    2 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    3 Sharp Oncology (Comprehensive Breast Care of San Diego) San Diego California United States 92123
    4 Comprehensive Breast Care of Denver Denver Colorado United States 80218
    5 The University of Kansas Cancer Center Westwood Kansas United States 66205
    6 Columbia New York New York United States 10032

    Sponsors and Collaborators

    • University of Arkansas
    • Angiodynamics, Inc.

    Investigators

    • Principal Investigator: Daniela Ochoa, MD, University of Arkansas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Arkansas
    ClinicalTrials.gov Identifier:
    NCT01153035
    Other Study ID Numbers:
    • 104603
    • NCT01420380
    First Posted:
    Jun 29, 2010
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Mar 1, 2022
    Keywords provided by University of Arkansas
    Breast Conservation Therapy
    Lumpectomy
    Radiofrequency Ablation
    Radiation
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Mar 23, 2022