ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Arkansas
- Enrollment
- 104
- Locations
- 12
- Primary Endpoint
- Estimate the re-excision rate for close (<3mm) or positive margins
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported