MarginProbe® – Final results of the German post-market study in breast conserving surgery of ductal carcinoma in situ

Thill, Marc; Dittmer, C.; Baumann, Kristin; Friedrichs, Kay; Blohmer, Jens-Uwe

doi:10.1016/j.breast.2013.11.002

Cited by 40 publications

(24 citation statements)

References 9 publications

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“…Both SR and IOUS guided surgery can be used directly by surgeons within the operating theatre; however neither technique is as accurate as pathological approaches and both are subject to intraobserver error [34]. A common limitation of all emerging technologies such as MarginProbe™ [23, 24], ClearEdge™ [25] or OCT [30] is the need to disrupt workflow demanding an additional probe during resection or specimen analysis following resection. Following excision, the exact orientation of the surgical specimen can prove to be challenging and this may affect accurate margin identification.…”

Section: Discussionmentioning

confidence: 99%

“…A variety of imaging and probe-based devices are emerging that are designed to detect differences in tissue properties between cancerous and normal breast tissue [22]. Bioimpedance is the measure of the response of tissue to an externally applied electrical current; the MarginProbe™ is quick (~5–7 minutes) and a 50% reduction in re-operation rates is achievable despite modest sensitivity and specificity (~70%) [23, 24]. Similarly, the ClearEdge™ system measures tissue-specific electrical properties with promising preliminary data (sensitivity ~85%, specificity ~80%) [25].…”

Section: Introductionmentioning

confidence: 99%

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Rapid evaporative ionisation mass spectrometry of electrosurgical vapours for the identification of breast pathology: towards an intelligent knife for breast cancer surgery

et al. 2017

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BackgroundRe-operation for positive resection margins following breast-conserving surgery occurs frequently (average = 20–25%), is cost-inefficient, and leads to physical and psychological morbidity. Current margin assessment techniques are slow and labour intensive. Rapid evaporative ionisation mass spectrometry (REIMS) rapidly identifies dissected tissues by determination of tissue structural lipid profiles through on-line chemical analysis of electrosurgical aerosol toward real-time margin assessment.MethodsElectrosurgical aerosol produced from ex-vivo and in-vivo breast samples was aspirated into a mass spectrometer (MS) using a monopolar hand-piece. Tissue identification results obtained by multivariate statistical analysis of MS data were validated by histopathology. Ex-vivo classification models were constructed from a mass spectral database of normal and tumour breast samples. Univariate and tandem MS analysis of significant peaks was conducted to identify biochemical differences between normal and cancerous tissues. An ex-vivo classification model was used in combination with bespoke recognition software, as an intelligent knife (iKnife), to predict the diagnosis for an ex-vivo validation set. Intraoperative REIMS data were acquired during breast surgery and time-synchronized to operative videos.ResultsA classification model using histologically validated spectral data acquired from 932 sampling points in normal tissue and 226 in tumour tissue provided 93.4% sensitivity and 94.9% specificity. Tandem MS identified 63 phospholipids and 6 triglyceride species responsible for 24 spectral differences between tissue types. iKnife recognition accuracy with 260 newly acquired fresh and frozen breast tissue specimens (normal n = 161, tumour n = 99) provided sensitivity of 90.9% and specificity of 98.8%. The ex-vivo and intra-operative method produced visually comparable high intensity spectra. iKnife interpretation of intra-operative electrosurgical vapours, including data acquisition and analysis was possible within a mean of 1.80 seconds (SD ±0.40).ConclusionsThe REIMS method has been optimised for real-time iKnife analysis of heterogeneous breast tissues based on subtle changes in lipid metabolism, and the results suggest spectral analysis is both accurate and rapid. Proof-of-concept data demonstrate the iKnife method is capable of online intraoperative data collection and analysis. Further validation studies are required to determine the accuracy of intra-operative REIMS for oncological margin assessment.Electronic supplementary materialThe online version of this article (doi:10.1186/s13058-017-0845-2) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Rapid evaporative ionisation mass spectrometry of electrosurgical vapours for the identification of breast pathology: towards an intelligent knife for breast cancer surgery

et al. 2017

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“…On the downside, limited sensitivity, specificity, field of view, and penetration imply that complete margin assessment is neither practical nor possible, leading to a possibility of missed malignant tissue within the margin. 12 Intraoperative ultrasound (US) examination is a convenient, nondestructive method with reported high specificity; however, it remains unable to overcome sensitivity problems in younger and denser breasts especially with high-grade tumors exhibiting intraductal components. 13,14 Alternatively, recent studies using optical techniques, such as Raman spectroscopy, autofluorescence spectroscopy, optical coherence tomography, and diffuse reflectance spectroscopy have demonstrated superior soft tissue contrast, resulting in margin assessment sensitivity as high as 100% and specificity of nearly 92%.…”

Section: Overviewmentioning

confidence: 99%

Intraoperative photoacoustic screening of breast cancer: a new perspective on malignancy visualization and surgical guidance

et al. 2019

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High re-excision rates in breast-conserving surgery call for a new intraoperative approach to the lumpectomy margin evaluation problem. The unique intraoperative imaging system, presented here, demonstrated the capability of photoacoustic tomography (PAT) to deliver optical sensitivity and specificity, along with over 2-cm imaging depth, in a clinical setting. The system enabled the evaluation of tumor extent, shape, morphology, and position within lumpectomy specimens measuring up to 11 cm in diameter. The investigation included all major breast cancer-related lesions, such as invasive ductal carcinoma (IDC), multifocal IDC, ductal carcinoma in situ and combinations of these variants. Coregistration with established ultrasound (US) technology, as well as comparison to specimen radiography, validated the performance of PAT, which appeared to facilitate better tumor visualization. Contrary to expected PA contrast mechanisms, PAT images of hemoglobin distribution correlated poorly with US-determined tumor location, while hypointense regions in lipid-weighted PAT images were in better agreement with US.

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“…Optical coherence tomography demonstrated higher scattering tissue with a heterogeneous pattern is a marker of tumor cells and tumor tissue relative to normal breast tissue, and found in a small case series a very encouraging sensitivity of 100% and specificity of 82% . A novel handheld device, the MarginProbe (Dune Medical Devices, Caesarea, Israel), has demonstrated high sensitivity (97% for tumors greater than 0.7 mm) and specificity (87% on relatively homogeneous sites) . This device has also been shown to reduce re‐excisons in patient with DCIS by more than 50% .…”

Section: Improving Intraoperative Assesement Of Marginsmentioning

confidence: 99%

The importance of surgical margins in breast cancer

Priddy

Forte

Lang

2015

Journal of Surgical Oncology

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Achieving negative margins with "no tumor on ink" is an appropriate goal in breast conserving therapy (BCT). Wider margins do not decrease recurrence rates, and re-excision in patients with microscopic positive margins is warranted. Several strategies exist to increase rates of negative margins, including techniques to improve tumor localization, intraoperative assessment of margins and oncoplastic techniques. Negative margins should be the goal of BCT, as this will improve both local control and long-term survival.

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MarginProbe® – Final results of the German post-market study in breast conserving surgery of ductal carcinoma in situ

Cited by 40 publications

References 9 publications

Rapid evaporative ionisation mass spectrometry of electrosurgical vapours for the identification of breast pathology: towards an intelligent knife for breast cancer surgery

Rapid evaporative ionisation mass spectrometry of electrosurgical vapours for the identification of breast pathology: towards an intelligent knife for breast cancer surgery

Intraoperative photoacoustic screening of breast cancer: a new perspective on malignancy visualization and surgical guidance

The importance of surgical margins in breast cancer

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