Clinical trial · Interventional
Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation
NCT00571987CI-TRIAL-00019931eRFAcompletedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- description
- This is a non-randomized one arm study, all subjects receive treatment (radiofrequency ablation).
- interventionNames
- Device: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)
Primary outcomes (1)
- measure
- Number of Patients Requiring 2nd Surgery for Close or Positive Margins
- timeFrame
- Margins assessed at Final Pathology, approximately 1 week post-RF surgery
- description
- A "close" surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a "wide" surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined "close" as less than 3 mm.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (4)
- BACKGROUNDKlimberg 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. PMID 17009144
- BACKGROUNDKlimberg 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. PMID 21904959
- BACKGROUNDMackey 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. PMID 22422482
- BACKGROUNDKlimberg 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. PMID 24655863