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What is a potential drawback of using frozen section in breast cancer diagnosis?
What is the primary benefit of using the Margin Probe system in breast cancer surgery?
What is a potential consequence of using full cavity shave in breast cancer surgery?
What is a limitation of using full cavity shave in breast cancer surgery?
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What is the primary goal of using intraoperative imaging in breast cancer surgery?
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What is a necessary condition for a patient to be enrolled in the pivotal study?
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What is the purpose of suture marking the center of each of the 6 margins of the main lumpectomy specimen?
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What is the primary purpose of the MarginProbe device in the SOC+Device arm?
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What would disqualify a patient from enrolling in the pivotal study?
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What is NOT a step in the resection process of the main lumpectomy specimen?
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What is the primary effectiveness endpoint in the study?
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What is the definition of a positive margin in the study?
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What is the role of intraoperative imaging in the study?
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How many patients were excluded from the study due to protocol violations or not meeting the inclusion/exclusion criteria?
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What is the total number of patients analyzed in the study?
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How many patients were analyzed in the 'device' arm of the NPL subgroup?
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What was the reason for excluding one patient from the study?
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How many patients were analyzed in the 'control' arm of the study?
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What percentage of patients with long-term 'excellent' or 'good' cosmetic evaluation was similar in both arms?
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How many margins were re-excised by the surgeons in the entire cohort and NPL subgroup, respectively?
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What percentage of margins in the entire cohort were not re-excised?
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Why did the surgeons not re-excise the remaining 43% of device-detected positive margins?
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What would have been the consequence of re-excising the remaining 43% of device-detected positive margins?
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What percentage of patients in the 'device' arm were able to intraoperatively re-excise all histologically positive margins?
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What is the approximate percentage of patients taken back to the operating room for additional surgery when the device was used?
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What percentage of correct intraoperative reactions and reoperation rates were maintained in the control arm?
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What is the increase in percentage of patients who were able to intraoperatively re-excise all histologically positive margins when using the device?
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What is the approximate percentage of patients in the 'device' arm who underwent preoperative image-guided localization?
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What percentage of American women with early-stage breast cancer are treated with BCS?
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What is the goal of a lumpectomy procedure in breast cancer treatment?
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Why is it challenging to accomplish a successful lumpectomy?
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What is a consequence of involved or positive lumpectomy margins?
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What is a common occurrence for patients undergoing lumpectomy?
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What was the re-excision rate in the control group in the study by Allweis et al.?
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What was the relative reduction in re-excision rates with the use of MarginProbe?
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How many patients were enrolled in the study by Thill et al.?
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What was the re-excision rate in the MarginProbe group in the study by Coble et al.?
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What was the study design of the study by Schnabel et al.?
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What was the reduction in re-excision rates in the study by Hermann et al.?
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What was the cosmesis outcome in the study by Geha et al.?
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What was the re-excision rate in the control group in the study by Kupstas et al.?
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What was the relative reduction in re-excision rates with the use of MarginProbe in the study by Cen et al.?
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What was the study design of the study by Arch et al.?
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What is the estimated percentage of cases where reoperation for positive margins after BCS may be necessary?
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What is the consequence of having tumor cells directly at the margin of the excised specimen?
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What is the recommended course of action for patients not amenable to margin-free lumpectomy?
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What percentage of American women with early-stage breast cancer are treated with breast-conserving surgery (BCS)?
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What is the estimated percentage of main lumpectomy specimens that will have positive or close margins?
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What is the primary goal of a lumpectomy procedure in breast cancer treatment?
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What is the purpose of evaluating margin status during lumpectomy?
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Why is it challenging to accomplish a successful lumpectomy?
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What is the consequence of having involved or positive lumpectomy margins?
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What is the primary goal of breast-conserving surgery (BCS) for breast cancer?
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What is a consequence of involved or positive lumpectomy margins?
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What is the goal of achieving negative margins during lumpectomy?
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What is a leading risk factor for local recurrence in breast cancer?
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What is the role of pathology data in the evaluation of lumpectomy margin status?
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What is a common occurrence for patients undergoing lumpectomy?
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What is excluded from the study?
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What was the outcome of using the MarginProbe device in the study?
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What is done to the main lumpectomy specimen?
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What was the significance of the MarginProbe device in breast cancer surgery?
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What is the consequence of involved or positive lumpectomy margins?
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What is obtained from all patients in the study?
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What percentage of patients in the 'device' arm were able to intraoperatively re-excise all histologically positive margins?
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What was the outcome of the study in terms of cosmetic outcome?
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What is a common occurrence for patients undergoing lumpectomy?
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What is the primary objective of re-excision in breast-conserving surgery for cancer?
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What is the typical practice of surgeons and pathologists when dividing a lumpectomy specimen?
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What is the consequence of involved or positive lumpectomy margins in breast cancer treatment?
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What is the goal of a lumpectomy procedure in breast cancer treatment?
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Why is it challenging to accomplish a successful lumpectomy?
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What is the significance of re-excision in breast cancer surgery?
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What is the common occurrence for patients undergoing lumpectomy?
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What percentage of American women with early-stage breast cancer are treated with breast-conserving surgery?
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Study Notes
Patient Diagnosis by Treatment Group
- 24 (8.1%) patients in the device group had invasive ductal carcinoma, 22 (7.4%) in the control group, and 7 (10.3%) in the roll-in phase.
- 26 (8.7%) patients in the device group had invasive lobular carcinoma, 13 (4.4%) in the control group, and 2 (2.9%) in the roll-in phase.
- 83 (27.9%) patients in the device group had ductal carcinoma in situ, 78 (26.2%) in the control group, and 19 (27.9%) in the roll-in phase.
- 155 (52.0%) patients in the device group had mixed diagnoses, 179 (60.1%) in the control group, and 39 (57.4%) in the roll-in phase.
Tumor Stage Results
- The majority of patients were diagnosed with stage II breast cancer and below.
Margin Probe
- The Margin Probe is a device that identifies, in real-time, positive margins by detecting microscopic residual cancer and DCIS at the surface of excised breast tissue.
- The device enables immediate action by the surgeon, thereby reducing the need for re-excision surgery.
Limitations of Current Margin Assessment Methods
- Gross assessment and specimen X-ray cannot palpate/visualize microscopic invasive cancer nor DCIS.
- Frozen section analysis is difficult due to the fatty nature of breast tissue and may add significant time to the procedure.
- Full cavity shave can compromise cosmetic outcomes due to the volume of healthy tissue removed.
Patient Study Inclusion and Exclusion Criteria
- Inclusion criteria: women histologically diagnosed with carcinoma of the breast, non-palpable malignant lesions, undergoing lumpectomy, and aged 18 years or more.
- Exclusion criteria: multicentric disease, bilateral disease, neoadjuvant systemic therapy, previous radiation, prior surgical procedure, implants, pregnancy, and lactation.
Patient Treatment
- Patients were first enrolled and taken to the operating room for resection of the main lumpectomy specimen.
- The main lumpectomy specimen and lumpectomy cavity palpation and related re-excisions were performed before patient randomization.
- Patients were then randomized to either the standard of care (SOC) or SOC+Device arm intraoperatively.
Study Endpoints
- The primary effectiveness endpoint is measured as all pathologically positive margins on the main specimen being intraoperatively re-excised or “addressed”.
- A positive margin is defined as a margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked margin.
Background
- Breast cancer is a common disease, and breast-conserving surgery (BCS) is a treatment option.
- BCS involves removing the tumor and a margin of surrounding normal breast tissue.
- Complete removal of the malignancy is crucial, but challenging due to the microscopic extent of breast cancer.
Study Details
- The study was a randomized, double-arm trial to evaluate the benefit of a novel device (MarginProbe) in intraoperative margin assessment for BCS.
- 300 patients were enrolled, with 293 patients analyzed (143 in the "device" arm and 150 in the "control" arm).
- The device was applied to the lumpectomy specimen, and additional tissue was excised according to device readings.
Results
- The device group had a higher rate of correct surgical reaction confirmed by histology compared to the control group.
- In the device group, 76% of patients had "excellent" or "good" cosmetic evaluation, similar to the control group.
- The device improved intraoperative re-excision of positive margins, with a 75% increase compared to the control arm.
- In the NPL subgroup, device use reduced reoperation rates by over 50%.
Non-Palpable Lesions (NPL) Subgroup
- 168 patients were analyzed in the NPL subgroup (82 in the device arm and 86 in the control arm).
- The device improved correct intraoperative reaction and reduced reoperation rates in the NPL subgroup.
Conclusion
- The study demonstrates the benefit of the MarginProbe device in intraoperative margin assessment for BCS, particularly in the NPL subgroup.
- The device improves the detection and re-excision of positive margins, reducing reoperation rates and improving cosmetic outcomes.
MarginProbe Peer-reviewed Literature
- Significant and consistent reduction in positive margins and re-excision rates across multiple studies:
- 23% reduction in re-excision rates
- 56% reduction in positive margins
- Studies published in various journals, including Am J Surg, Ann Surg, SpringerPlus, and Breast J
- Study designs: Prospective, randomized, controlled, multicenter, and retrospective
- Patient populations: 293 to 596 patients
- Re-excision rates:
- Control group: 12.7% to 39%
- MarginProbe group: 5.6% to 18.3%
- Reduction in re-excision rates: 56% to 88%
- Cosmesis: favorable in most studies
Positive Margins and Re-excision Rates
- Positive margins: significant risk factor for local recurrence
- Re-excision rates: up to 50% of cases
- National Comprehensive Cancer Network guidelines: positive lumpectomy margins require reoperation
- Standard practice: unacceptable to have tumor cells directly at the margin of the excised specimen
MarginProbe Device
- Intraoperative probe for positive margin detection in breast-conserving surgery
- Associated with improved correct surgical reaction and decreased re-excision rates
- Safe and effective in reducing the rate of repeat operations
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Description
This quiz analyzes patient diagnosis by treatment group, including roll-in, device, control, and all phases. It focuses on invasive ductal carcinoma and other types of cancer.