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| ID | Type | Description | Link |
|---|---|---|---|
| NIH Grant 5 R21 CA097715-01 |
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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
| Ethicon Endo-Surgery | INDUSTRY |
| RITA Medical Systems | INDUSTRY |
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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).
Using the Mammotome Breast Biopsy System (IVEB) in conjunction with MRI to predict extent of disease, ultrasound to direct removal of the tumor, touch preparation cytology for diagnosis, and ablation of margins using radiofrequency ablation (RFA), we propose to develop a comprehensive system for same-day diagnosis and treatment of patients with small breast lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Removal and Margin Ablation | Procedure | Patients with a diagnosis of unicentric invasive breast cancer diagnosed by IVEB will then be assigned to the next available surgery date. On that day, the patient's axillary staging will be done, followed by ablation of the biopsy cavity using RFA. The breast surgery may include lumpectomy (which will be directed with US-guidance to assure more accurate removal of the en bloc IVEB site and the margin zone of ablation) or simple mastectomy with or without reconstruction. The tissue specimen will be sent immediately from the operating room to Pathology for routine processing. |
| Measure | Description | Time Frame |
|---|---|---|
| To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation | Post-surgical pathology review |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with viable tumor cells beyond the margin | Post-surgical pathology review |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| V. Suzanne Klimberg, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas For Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12488164 | Background | Johnson 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. | |
| 21904959 | Result | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D015412 | Mastectomy, Segmental |
| D008408 | Mastectomy |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| D017437 |
| Skin and Connective Tissue Diseases |