Excision Followed by Radiofrequency Ablation for Breast Cancer (ABLATE)
This study is currently recruiting participants.
Verified April 2013 by University of Arkansas
Sponsor:
University of Arkansas
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
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Purpose
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 | Intervention |
|---|---|
|
Breast Cancer |
Device: Radiofrequency Ablation |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by University of Arkansas:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 250 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Surgery followed by RFA |
Device: Radiofrequency Ablation
Breast conservation surgery followed by Radiofrequency Ablation of the cavity
Other Name: AngioDynamics, Inc.
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153035
Contacts
| 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 |
Locations
| United States, Arizona | |
| University of Arizona | Recruiting |
| Tucson, Arizona, United States, 85704 | |
| Contact: Monica Delbridge 520-694-2873 | |
| Principal Investigator: Rebecca Viscusi, MD | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Adkins lladkins@uams.edu | |
| Contact: McCarthy mamccarthy@uams.edu | |
| Principal Investigator: Suzanne Klimberg, MD | |
| United States, California | |
| Sharp Oncology (Comprehensive Breast Care of San Diego) | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Lisa Obregon, RN, BSN, OCN 858-939-5052 | |
| Principal Investigator: Julie Barone, DO | |
| United States, Kansas | |
| The University of Kansas Cancer Center | Recruiting |
| Westwood, Kansas, United States, 66205 | |
| Contact: Stella Baccaray, RN | |
| Principal Investigator: Marilee McGinness, MD | |
| United States, New York | |
| Columbia | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Amiya Vaz 212-305-1317 | |
| Principal Investigator: Sheldon Marc Feldman, MD | |
Sponsors and Collaborators
University of Arkansas
Angiodynamics, Inc.
Investigators
| Principal Investigator: | Suzanne Klimberg, MD | University of Arkansas |
More Information
Publications:
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT01153035 History of Changes |
| Obsolete Identifiers: | NCT01420380 |
| Other Study ID Numbers: | 104603 |
| Study First Received: | June 24, 2010 |
| Last Updated: | April 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Arkansas:
|
Breast Conservation Therapy Lumpectomy Radiofrequency Ablation Radiation |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013