Excision Followed by Radiofrequency Ablation for Breast Cancer (ABLATE)

This study is currently recruiting participants.

Verified April 2013 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: April 25, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 24, 2010

Last Updated Date

April 25, 2013

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01153035 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Excision Followed by Radiofrequency Ablation for Breast Cancer

Official Title ^ICMJE

ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Device: Radiofrequency Ablation

Breast conservation surgery followed by Radiofrequency Ablation of the cavity

Other Name: AngioDynamics, Inc.

Study Arm (s)

Surgery followed by RFA

Intervention: Device: Radiofrequency Ablation

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

250

Estimated Completion Date

June 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01153035

Other Study ID Numbers ^ICMJE

104603

Has Data Monitoring Committee

Not Provided

Responsible Party

University of Arkansas

Study Sponsor ^ICMJE

University of Arkansas

Collaborators ^ICMJE

Angiodynamics, Inc.

Investigators ^ICMJE

Principal Investigator:

Suzanne Klimberg, MD

University of Arkansas

Information Provided By

University of Arkansas

Verification Date

April 2013

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

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