Intraoperative margin assessment with the MarginProbe at different mammographic breast densities.

47 Background: Mammographic breast density (BD) is known to affect breast imaging. MarginProbe is an RF Spectroscopy intraoperative margin assessment tool. We looked at the effect of mammographic breast density (BD) on the performance of the device. Mammographic density was assigned by Breast Imaging-Reporting and Data System (BI-RADS) classification prior to breast conserving surgery with the MarginProbe. Methods: For the current study we analyzed MarginProbe device arm data from the MarginProbe Pivotal Trial for which BD data was available. Clear margins of the main specimen, which is where the MarginProbe was applied, were defined as no tumor on ink. Clinical benefit was defined as clearing positive main specimen margins or cancer in the shaving. Analysis was performed based on logistic and linear regression, with univariate analysis. Results: The dataset for the analysis included 196 patients for which preoperative BD data was available. With higher BD, there was an increase in the rate of main lumpectomy specimen with positive margins (OR 1.65 per change in density category, p=0.025). The rate of shavings with clinical benefit showed an upward trend, with increasing BD. The number of shavings per patient increased with BD, however the overall volume of shavings did not increase. There was an increase in the per patient relative clinical benefit as BD increased (OR 1.6 per change in density category, p=0.024). Conclusions: With higher breast density patients and surgeons face an increase in risk for main specimen positive margins. With the increased BD and main specimen positivity more shavings were removed, but shavings volume did not increase as average shaving volume decreased with higher BD. Higher level of patient clinical benefit was observed with higher BD.

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Intraoperative Evaluation of Resection Margins in Breast-Conserving Surgery for In Situ and Invasive Breast Carcinoma

Breast Cancer Basic and Clinical Research ◽

10.1177/1178223421993459 ◽

2021 ◽

Vol 15 ◽

pp. 117822342199345

Author(s):

Caroline Koopmansch ◽

Jean-Christophe Noël ◽

Calliope Maris ◽

Philippe Simon ◽

Marième Sy ◽

...

Keyword(s):

Invasive Carcinoma ◽

Tumour Size ◽

Breast Conserving Surgery ◽

Margin Status ◽

Resection Margins ◽

Margin Assessment ◽

Positive Margins ◽

Intraoperative Assessment ◽

Intraoperative Margin Assessment

Background: The challenge of breast-conserving surgery (BCS) is to remove the entire tumour with free margins and avoid secondary excision that may adversely affect the cosmetic outcome. Consequently, intraoperative evaluation of surgical margins is critical. The aims of this study were multiple. First, to analyse our methodology of intraoperative examination of the resection margins and to evaluate radiological and pathological methods in the assessment of the surgical margins. Second, to evaluate the factors associated with positive margins in our patient population. M&m: The data on the resection margin status of 290 patients who underwent BCS for invasive carcinoma or ductal carcinoma in situ (DCIS) between 2009 and 2016 were reviewed. Results: In the cohort of BCS with invasive carcinoma, the negative predictive value was 97.4% for intraoperative assessment by radiography and 81.8% for intraoperative assessment by pathology. The re-operation rate among cases without intraoperative assessment was 23.6% compared to 7.3% among cases with intraoperative assessment ( P = .003). Margin status was significantly associated with tumour size, histological subtype (invasive lobular carcinoma), and multifocality. In the population of BCS with DCIS, margin status was significantly associated with preoperative localisation and intraoperative margin assessment ( P = .03). Conclusion: There is no statistical difference between pathological and radiological intraoperative assessment. Tumour size, lobular subtype, and multifocality were found to be significantly associated with positive margins in cases with invasive carcinoma, whereas absence of intraoperative margin assessment was significantly associated with positive margins in cases with DCIS. Therefore, intraoperative margin assessment improves the likelihood of complete excision of the lesion.

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Minimizing re-excision after breast conserving surgery – a review of radiofrequency spectroscopy for real-time, intraoperative margin assessment

Expert Review of Medical Devices ◽

10.1080/17434440.2021.1992273 ◽

2021 ◽

Author(s):

Vincent J. Reid ◽

Jeffrey S. Falk ◽

Alice M. Police ◽

Calvin A. Ridgeway ◽

Lisa L. Cadena ◽

...

Keyword(s):

Real Time ◽

Breast Conserving Surgery ◽

Margin Assessment ◽

Intraoperative Margin Assessment

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OBTAINING ADEQUATE SURGICAL MARGIN STATUS IN BREAST-CONSERVATION THERAPY: INTRAOPERATIVE ULTRASOUND-GUIDED RESECTION VERSUS SPECIMEN MAMMOGRAPHY

Medicine and Pharmacy Reports ◽

10.15386/cjmed-891 ◽

2018 ◽

Vol 91 (2) ◽

pp. 197-202

Author(s):

Maria Mihaela Pop ◽

Silviu Cristian ◽

Orsolya Hanko-Bauer ◽

Dana Valentina Ghiga ◽

Rares Georgescu

Keyword(s):

Sensitivity And Specificity ◽

Breast Conservation ◽

Intraoperative Ultrasound ◽

Positive Margin ◽

Margin Status ◽

Resected Specimen ◽

Margin Assessment ◽

Positive Margins ◽

Positive Correlation ◽

Intraoperative Margin Assessment

Background and aim. The purpose of breast-conserving surgery (BCS) for women with cancer is to perform an oncological radical procedure with disease-free margins at the final histological assessment and with the best aesthetic result possible. Intraoperative resected specimen ultrasound and intraoperative resected specimen mammography may reduce the rates of positive margins and reexcision among patients undergoing conserving therapy. Our objective is to compare the two methods with the histopathological results for a preset cut off and asses which parameters can influence the positive margin status.Method. A prospective study was performed on 83 patients who underwent breast conservation surgery for early breast cancer (pT1-3a pN0-1 M0) between 2014 and 2016. After excision the specimen was oriented in the operating room by the surgeon. Metallic clips and threads were placed on margins: one clip and the long thread at 12 o'clock, two clips and the short threads at 9 o'clock. The next step was intraoperative ultrasound assessment of the specimen. For the margins under 2 mm we performed selective margin shaving, followed by mammography to identify and document the lesion and finally histopathological examination of the specimen with reporting the gross and microscopic margins. The positive margins required re-excision or boost of radiation at the posterior or anterior margins, depending on the case.Results. We set a cut-off at 2 mm. The sensitivity and specificity of the intraoperative margin assessment via the ultrasound method were 90.91% (95% CI 70.84-98.88%) and 67.21% (95% CI 54-78.69%) respectively. The sensitivity and specificity of the intraoperative margin assessment via the mammographic procedure were 45.45% (95% CI 24.39-67.79%) and 85.25% (95% CI 73.83-93.02%) respectively. There was positive correlation between the histopathological and intraoperative ultrasound exam (p=0.018) and negative correlation between the histopathological exam and the post-operative mammographic exam (p=0.68). We found a positive correlation between the positive margin status and age (<40), preoperative chemotherapy, intraductal carcinoma, inflammatory process around the tumor, and the immunohistochemical triple negative profile.Conclusions. According to our results, the intraoperative ultrasound of the breast specimen for a cutt-off at 2 mm can decrease the rates of margin positivity compared to the mammographic procedure and has the potential to diminish the number of subsequent undesired re-excisions.

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Combined experience at three breast centers with routine use of an intraoperative margin assessment device including comparison to historical re-excision rates.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.26_suppl.79 ◽

2014 ◽

Vol 32 (26_suppl) ◽

pp. 79-79 ◽

Cited By ~ 1

Author(s):

Mary L. Sebastian ◽

Alice Marie Police ◽

Stephanie Akbari ◽

Beth Anglin

Keyword(s):

Assessment Tool ◽

Local Therapy ◽

The United States ◽

High Rate ◽

Breast Cancer Patients ◽

Margin Assessment ◽

Surgical Interventions ◽

Breast Centers ◽

Intraoperative Margin Assessment ◽

The Impact

79 Background: Historically there has been a high rate of surgical interventions to obtain clear margins for breast cancer patients undergoing breast conserving local therapy. This study is the first compellation of data among three breast centers to assess the impact of an intraoperative margin assessment tool (MarginProbe) on re-excision rates. This device has been approved for clinical use in the United States since 2013. We present groups of consecutive patients in each of these breast centers – before and after the implementation of routine intraoperative use of the margin assessment device during lumpectomy procedures. Methods: Lesions were localized by standard methods. The intraoperative margin assessment device was used on all circumferential margins of the main specimen, but not on any additional shavings. A positive reading by the device led to an additional shaving of the corresponding cavity location. Specimens were also imaged intra-operatively by X-ray, and additional shavings were taken if needed based on clinical assessment. We established the historical re-excision rates of each surgeon on a consecutive set of patients in a corresponding period just before we began using the device. Results: In total, 165 patients were treated in three institutions up until April 2014. Sixteen patients (9.7%, 16/165) required re-excision. Historical re-excision rates corresponding to periods of use before the intraoperative margin assessment device was put into use were 25.8% (48/186). The re-excision rate was reduced by 62% (P<0.0001). Six re-excisions were due to a positive shaving which was not measured by the device. Conclusions: Use of an intraoperative margin assessment device contributes to achieving clear margins and reducing re-excision procedures. As in some cases positive margins were found on shavings, future studies of interest may include an analysis of the effect of using the device on the shavings intra-operatively.

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