Clinical trial · Interventional
Percutaneous Removal and Margin Ablation for Breast Cancer
NCT00574301CI-TRIAL-00011471completedPhase 1 / Phase 2ClinicalTrials.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)
We hypothesize that radiofrequency ablation after single-insertion image guided vacuum assisted biopsy (IVEB) can be used to achieve negative margins in small unicentric breast cancers (≤1.5 cm).
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Percutaneous Removal and Margin Ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Procedure: Percutaneous Removal and Margin Ablation
Primary outcomes (1)
- measure
- To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation
- timeFrame
- Post-surgical pathology review
Secondary outcomes (1)
- measure
- The proportion of patients with viable tumor cells beyond the margin
- timeFrame
- Post-surgical pathology review
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Female, 18 to 90 years of age * Non-pregnant, not breastfeeding * Pre-study documentation of: * Size ≤1.5 cm cancer successfully removed by US-guided IVEB within 30 days of registration * Uni-centricity, unilateral cancer by radiology (mammogram and MRI) * Location of abnormality \> 1 cm from the skin * Ductal Carcinoma, Invasive (Grade I-III) or In-Situ * No palpable axillary or supraclavicular lymph nodes * Good general health * Zubrod Performance Status of 0, 1, or 2 * If prior non-breast malignancy, must have 5 year disease-free survival * No prior chemotherapy * Hormonal therapy must be stopped * Therapy with tamoxifen must have been of 14 days or less duration Exclusion Criteria: * Subjects less than 18 years of age or greater than 90 years of age * Pregnant or breastfeeding * Male * Prior Breast Biopsy affected breast * Breast implants * Multicentric disease, bilateral disease * Residual disease after IVEB of \> 1cm on MRI * Lesions \> 1.5 cm in diameter * Lesions \< 1 cm from skin surface * Previous radiation therapy to the breast
References
Publications (2)
- BACKGROUNDJohnson AT, Henry-Tillman RS, Smith LF, Harshfield D, Korourian S, Brown H, Lane S, Colvert M, Klimberg VS. Percutaneous excisional breast biopsy. Am J Surg. 2002 Dec;184(6):550-4; discussion 554. doi: 10.1016/s0002-9610(02)01099-1. PMID 12488164
- RESULTKlimberg 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