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The study objective is to determine the MarginProbe® System's diagnostic accuracy at the margin level and impact on Positive Margin* Presence originating from the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery.
*A positive margin is defined in this study as a margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked surface
This is a prospective, multicenter, randomized (1:1), double arm, controlled study, in which subjects undergoing breast excision (lumpectomy) for carcinoma of the breast will be randomized to either standard of care with additional inspection ('SOC + Additional inspection' arm) or standard of care with MarginProbe as an adjunct ('SOC + Device' arm).
The MarginProbe is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision. It will be used by the surgeon during lumpectomy procedures only in patients randomized to the "Device+SOC" arm.
Randomization will take place following the excision of the main ex-vivo lumpectomy specimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOC + Device | Other | The surgeon will perform routine standard of care lumpectomy with adjunctive MarginProbe device use on the main ex-vivo lumpectomy specimen. |
|
| SOC + Additional Inspection | Other | The surgeon will perform routine standard of care lumpectomy with additional inspection on the main ex-vivo lumpectomy specimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Margin Probe | Device | The surgeon will use the MarginProbe System to identify cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy at the margin level | Sensitivity and Specificity at the margin level; | Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date |
| Incomplete Surgical Resection (ISR ) | ISR - Positive Margin on the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery, that was not addressed by taking a shaving(s) corresponding to the positive margin(s). | Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery | Proportion of patients with Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery | Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maya Livnat | Dilon Medical Technologies Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States | ||
| Baptist MD Anderson Cancer Center |
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| Label | URL |
|---|---|
| A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies. | View source |
| Dune Medical Devices official website | View source |
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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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| Control: Additional inspection | Other | The surgeon will perform additional inspection and assessment of the margins of the main ex-vivo lumpectomy specimen following primary excision |
|
| Cosmesis evaluation | Objective evaluation by an evaluator blinded to arm assignment | participants will be followed until 6 months ± 1 month after last surgical treatment visit, an avarage of of 8 months following initial lumpectomy |
| Repeat lumpectomy rate | Proportion of patients who underwent a repeat lumpectomy procedure | Participants will be followed for 2-5 weeks (average) |
| Repeat lumpectomy and mastectomy rate | Proportion of patients who underwent a repeat lumpectomy procedure or a mastectomy | Participants will be followed for 2-5 weeks (average) |
| Diagnostic Accuracy at the Patient Level (ignoring location) | Proportion of patients from whom shavings were taken | Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date |
| Jacksonville |
| Florida |
| 32207 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| NorthShore University HealthSystem | Chicago | Illinois | 60201 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| John Hopkins Medicine | Baltimore | Maryland | 21287 | United States |
| Suburban Hospital | Bethesda | Maryland | 20817 | United States |
| Summit Medical Group | Berkeley Heights | New Jersey | 07922 | United States |
| New Mexico University Cancer center | Albuquerque | New Mexico | 87102 | United States |
| Montefiore Medical Center | New York | New York | 10461 | United States |
| PinnacleHealth Cancer Institute | Harrisburg | Pennsylvania | 17109 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |