Excision Followed by Radiofrequency Ablation for 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona, Tucson, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency Ablation

Device

Breast conservation surgery followed by Radiofrequency Ablation of the cavity

Other names: AngioDynamics, Inc.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

Angiodynamics, Inc.

Registry information

Official study title

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

Acronym: ABLATE

Important dates

Study start: 2010
Primary completion: 2027
Study completion: 2027
First posted: Jun 29, 2010
Registry last updated: Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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