Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation

NCT ID: NCT00571987

Last Updated: 2015-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2013-12-31

Brief Summary

In this protocol we combine two available and reliable treatments - lumpectomy and RFA. This combination method will provide for excision of the cancer as routinely accomplished and ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing large volumes of tissue. This combined open technique will allow for full histologic analysis of the primary tumor and margin. Because no extra tissue is removed from the breast to generate negative margins it will result in better cosmesis than re-excision to obtain negative margins.

Detailed Description

While RFA alone is not approved for tumor destruction in breast it is FDA-approved for ablation of soft tissue after the breast cancer is removed. This study seeks to remove the tumor and then ablate a tumor-free zone (margin) of tissue around the lumpectomy site instead of removing more tissue. The primary short-term goal is to obviate the need for re-excision in the event of close or positive margins (< 3 mm) which occurs on average in ~40 percent of the cases. Permanent pathology is only an estimation of margin status since 90% of recurrences occur at the site of the original lumpectomy. RFA ensures a sterilized margin regardless of the accuracy of the permanent pathology.

Conditions

Cancer of the Breast

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

This is a non-randomized one arm study, all subjects receive treatment (radiofrequency ablation).

Group Type: OTHER

AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)

Intervention Type: DEVICE

Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.

Interventions

AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)

Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Female, 18-100 years old
• Not pregnant or breastfeeding
• Pre-study radiologic documentation of:
• size ≤ 5 cm
• unicentric, unilateral
• suspicious mass or calcification
• BIRADS classification ≥ IV
• location of abnormality > 1 cm from skin
• Ductal or Infiltrating Ductal Carcinoma
• Grade I-III on final pathology
• Good general health
• Zubrod Performance Status of 0,1, or 2
• No previous chemotherapy
• No palpable axillary or supraclavicular lymph nodes
• If prior non-breast malignancy, must have > 5 year disease-free survival

Exclusion Criteria

• Patient < 18 y/o or > 100 y/o
• Pregnant or breastfeeding
• Male
• Breast implants
• Multicentric disease or bilateral disease
• Lesions > 5 cm in diameter
• Lesions < 1.0 cm from the skin
• Previous prior radiation to the breast
• Need for mastectomy
• Diffuse microcalcifications (as determined by the Investigator)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Angiodynamics, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

V. Suzanne Klimberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas For Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

References

Klimberg VS, Kepple J, Shafirstein G, Adkins L, Henry-Tillman R, Youssef E, Brito J, Talley L, Korourian S. eRFA: excision followed by RFA-a new technique to improve local control in breast cancer. Ann Surg Oncol. 2006 Nov;13(11):1422-33. doi: 10.1245/s10434-006-9151-4. Epub 2006 Sep 29.

Reference Type: BACKGROUND

PMID: 17009144 (View on PubMed)

Klimberg VS, Boneti C, Adkins LL, Smith M, Siegel E, Zharov V, Ferguson S, Henry-Tillman R, Badgwell B, Korourian S. Feasibility of percutaneous excision followed by ablation for local control in breast cancer. Ann Surg Oncol. 2011 Oct;18(11):3079-87. doi: 10.1245/s10434-011-2002-y. Epub 2011 Sep 9.

Reference Type: BACKGROUND

PMID: 21904959 (View on PubMed)

Mackey A, Feldman S, Vaz A, Durrant L, Seaton C, Klimberg VS. Radiofrequency ablation after breast lumpectomy added to extend intraoperative margins in the treatment of breast cancer (ABLATE): a single-institution experience. Ann Surg Oncol. 2012 Aug;19(8):2618-9. doi: 10.1245/s10434-012-2293-7. Epub 2012 Mar 16.

Reference Type: BACKGROUND

PMID: 22422482 (View on PubMed)

Klimberg VS, Ochoa D, Henry-Tillman R, Hardee M, Boneti C, Adkins LL, McCarthy M, Tummel E, Lee J, Malak S, Makhoul I, Korourian S. Long-term results of phase II ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial. J Am Coll Surg. 2014 Apr;218(4):741-9. doi: 10.1016/j.jamcollsurg.2013.12.032. Epub 2014 Jan 11.

Reference Type: BACKGROUND

PMID: 24655863 (View on PubMed)

Related Links

http://dx.doi.org/10.1016/j.jamcollsurg.2013.12.032

Long-Term Results of Phase II Ablation after Breast Lumpectomy Added to Extend Intraoperative Margins (ABLATE l) Trial Presented at the Southern Surgical Association 125th Annual Meeting, Hot Springs, VA, December 2013.

Other Identifiers

UAMS 29143

Identifier Type: -

Identifier Source: org_study_id