Detection Of Positive Margins Research Articles

Autofluorescence-Raman Spectroscopy for Ex Vivo Mapping Colorectal Liver Metastases and Liver Tissue

IntroductionIdentifying colorectal liver metastases (CRLM) during liver resection could assist in achieving clear surgical margins, which is an important prognostic variable for both disease-free and overall survival. The aim of this study was to investigate the effect of auto-fluorescence (AF) and Raman spectroscopy for ex vivo label-free discrimination of CRLMs from normal liver tissue. Secondary aims include exploring options for multimodal AF-Raman integration with respect to diagnosis accuracy and imaging speed on human liver tissue and CRLM. MethodsLiver samples were obtained from patients undergoing liver surgery for CRLM who provided informed consent (15 patients were recruited). AF and Raman spectroscopy was performed on CRLM and normal liver tissue samples and then compared to histology. ResultsAF emission spectra demonstrated that the 671 nm and 775/785 nm excitation wavelengths provided the highest contrast, as normal liver tissue elicited on average around eight-fold higher AF intensity compared to CRLM. The use of the 785 nm wavelength had the advantage of enabling Raman spectroscopy measurements from CRLM regions, allowing discrimination of CRLM from regions of normal liver tissue eliciting unusual low AF intensity, preventing misclassification. Proof-of-concept experiments using small pieces of CRLM samples covered by large normal liver tissue demonstrated the feasibility of a dual-modality AF-Raman for detection of positive margins within few minutes. ConclusionsAF imaging and Raman spectroscopy can discriminate CRLM from normal liver tissue in an ex vivo setting. These results suggest the potential for developing integrated multimodal AF-Raman imaging techniques for intraoperative assessment of surgical margins.

Single-institution experience of 500 pulmonary resections guided by intraoperative molecular imaging

ObjectiveIntraoperative molecular imaging (IMI) using tumor-targeted optical contrast agents can improve thoracic cancer resections. There are no large-scale studies to guide surgeons in patient selection or imaging agent choice. Here, we report our institutional experience with IMI for lung and pleural tumor resection in 500 patients over a decade. MethodsBetween December 2011 and November 2021, patients with lung or pleural nodules undergoing resection were preoperatively infused with 1 of 4 optical contrast tracers: EC17, TumorGlow, pafolacianine, or SGM-101. Then, during resection, IMI was used to identify pulmonary nodules, confirm margins, and identify synchronous lesions. We retrospectively reviewed patient demographic data, lesion diagnoses, and IMI tumor-to-background ratios (TBRs). ResultsFive hundred patients underwent resection of 677 lesions. We found that there were 4 types of clinical utility of IMI: detection of positive margins (n = 32, 6.4% of patients), identification of residual disease after resection (n = 37, 7.4%), detection of synchronous cancers not predicted on preoperative imaging (n = 26, 5.2%), and minimally invasive localization of nonpalpable lesions (n = 101 lesions, 14.9%). Pafolacianine was most effective for adenocarcinoma-spectrum malignancies (mean TBR, 2.84), and TumorGlow was most effective for metastatic disease and mesothelioma (TBR, 3.1). False-negative fluorescence was primarily seen in mucinous adenocarcinomas (mean TBR, 1.8), heavy smokers (>30 pack years; TBR, 1.9), and tumors greater than 2.0 cm from the pleural surface (TBR, 1.3). ConclusionsIMI may be effective in improving resection of lung and pleural tumors. The choice of IMI tracer should vary by the surgical indication and the primary clinical challenge.

Comparative Experience of Short-wavelength Versus Long-wavelength Fluorophores for Intraoperative Molecular Imaging of Lung Cancer.

Intraoperative molecular imaging (IMI) using tumor-targeted optical contrast agents can improve cancer resections. The optimal wavelength of the IMI tracer fluorophore has never been studied in humans and has major implications for the field. To address this question, we investigated 2 spectroscopically distinct fluorophores conjugated to the same targeting ligand. Between December 2011 and November 2021, patients with primary lung cancer were preoperatively infused with 1 of 2 folate receptor-targeted contrast tracers: a short-wavelength folate-fluorescein (EC17; λ em =520nm) or a long-wavelength folate-S0456 (pafolacianine; λ em =793nm). During resection, IMI was utilized to identify pulmonary nodules and confirm margins. Demographic data, lesion diagnoses, and fluorescence data were collected prospectively. Two hundred eighty-two patients underwent resection of primary lung cancers with either folate-fluorescein (n=71, 25.2%) or pafolacianine (n=211, 74.8%). Most tumors (n=208, 73.8%) were invasive adenocarcinomas. We identified 2 clinical applications of IMI: localization of nonpalpable lesions (n=39 lesions, 13.8%) and detection of positive margins (n=11, 3.9%). In each application, the long-wavelength tracer was superior to the short-wavelength tracer regarding depth of penetration, signal-to-background ratio, and frequency of event. Pafolacianine was more effective for detecting subpleural lesions (mean signal-to-background ratio=2.71 vs 1.73 for folate-fluorescein, P <0.0001). Limit of signal detection was 1.8cm from the pleural surface for pafolacianine and 0.3cm for folate-fluorescein. Long-wavelength near-infrared fluorophores are superior to short-wavelength IMI fluorophores in human tissues. Therefore, future efforts in all human cancers should likely focus on long-wavelength agents.

Machine-Learning Assisted Discrimination of Precancerous and Cancerous from Healthy Oral Tissue Based on Multispectral Autofluorescence Lifetime Imaging Endoscopy.

Simple SummaryComplete resection of dysplastic and malignant tissue improves overall survival and delays cancer recurrence in oral cancer patients; however, intraoperative surgical margin assessment is limited to visual inspection and palpation, making it difficult to achieve total resection. There is currently no tool capable of providing real-time, accurate, and continuous margin-assessment guidance during oral cancer resection surgery. Multispectral autofluorescence lifetime imaging (maFLIM) is a label-free imaging modality that enables quantifying a plurality of metabolic and compositional autofluorescence biomarkers of oral dysplasia and cancer. We have developed and validated a machine-learning assisted computer aided detection (CAD) system for automated discrimination of dysplastic and cancerous from healthy oral tissue based on in vivo widefield maFLIM endoscopy data. This CAD system can be potentially embedded into maFLIM endoscopes to enable continuous in situ detection of positive margins during oral cancer resection surgery, thus facilitating maximal tumor resection and improving surgical outcomes for oral cancer patients.Multispectral autofluorescence lifetime imaging (maFLIM) can be used to clinically image a plurality of metabolic and biochemical autofluorescence biomarkers of oral epithelial dysplasia and cancer. This study tested the hypothesis that maFLIM-derived autofluorescence biomarkers can be used in machine-learning (ML) models to discriminate dysplastic and cancerous from healthy oral tissue. Clinical widefield maFLIM endoscopy imaging of cancerous and dysplastic oral lesions was performed at two clinical centers. Endoscopic maFLIM images from 34 patients acquired at one of the clinical centers were used to optimize ML models for automated discrimination of dysplastic and cancerous from healthy oral tissue. A computer-aided detection system was developed and applied to a set of endoscopic maFLIM images from 23 patients acquired at the other clinical center, and its performance was quantified in terms of the area under the receiver operating characteristic curve (ROC-AUC). Discrimination of dysplastic and cancerous from healthy oral tissue was achieved with an ROC-AUC of 0.81. This study demonstrates the capabilities of widefield maFLIM endoscopy to clinically image autofluorescence biomarkers that can be used in ML models to discriminate dysplastic and cancerous from healthy oral tissue. Widefield maFLIM endoscopy thus holds potential for automated in situ detection of oral dysplasia and cancer.

The role of ultrasonography in head and neck Non-Melanoma Skin Cancer approach: an update with a review of the literature.

Non-Melanoma Skin Cancer is one of the most common cancer types and the face is the most affected region. The diagnosis of the skin cancer relies on clinical inspection, palpation, dermoscopy followed by incisional or excisional biopsy. When skin cancers are removed from the face, many factors are involved, including aesthetics. In addition, surgical planning with preoperative acknowledgement of the tumour margins is often the key to avoid incomplete excision, the need for reintervention, or in the prevention of functional and aesthetical defects in the treatment of skin tumours. In recent years, the development of new technologies in sonography, including high frequencies transducers can provide a full range of data. It can offer valuable information regarding the size of the tumour including the depth of invasion, the extent of the tumour, histology and subtypes of the lesions which are helpful for the treatment plan. It also may be efficient in detection of positive margins after surgery and it could play a role in the treatment of skin cancer, prevention of local recurrences and overall control of the disease. K.

Advantages of intraoperative digital specimen radiography (IDSR) in breast surgery.

e12613 Background: Breast cancer is in first place among malignant diseases in women in Russia. We can provide, in most cases, breast-conserving surgery (BCS), due to progress in early diagnosis. Evaluation of positive margins is still one of the most important objectives in breast-conserving surgery. Objectives: To assess the benefits of IDSR in BCS of patients with “carcinoma in situ”. Methods: The results of treatment of 55 patients with breast cancer “carcinoma in situ” in our clinic were evaluated in two comparable groups. Group A included 28 patients, who were operated on from January 2019 to June 2019 and had breast-conserving surgery without IDSR. Group B included 27 patients, who were operated on from June 2019 to January 2020 and had breast-conserving surgery with the evaluation of margins by IDSR. Results: In a planned histological examination positive margins were detected in group A in 4 cases (14%) and required reoperation. In group B all margins were clear. After IDSR, 6 (22%) patients out of 27 in this group showed microcalcifications in the resection margins or at a distance of less than 1 mm and required intraoperative additional excision to obtain clean margins. Conclusions: IDSR reduces the frequency of reoperation due to increased detection of positive margins, allows to correct scope and duration of surgery because of impact on the time of the surgical decision-making process.

Clinical label-free biochemical and metabolic fluorescence lifetime endoscopic imaging of precancerous and cancerous oral lesions

Incomplete head and neck cancer resection occurs in up to 85% of cases, leading to increased odds of local recurrence and regional metastases; thus, image-guided surgical tools for accurate, in situ and fast detection of positive margins during head and neck cancer resection surgery are urgently needed. Oral epithelial dysplasia and cancer development is accompanied by morphological, biochemical, and metabolic tissue and cellular alterations that can modulate the autofluorescence properties of the oral epithelial tissue. This study aimed to test the hypothesis that autofluorescence biomarkers of oral precancer and cancer can be clinically imaged and quantified by means of multispectral fluorescence lifetime imaging (FLIM) endoscopy. Multispectral autofluorescence lifetime images of precancerous and cancerous lesions from 39 patients were imaged in vivo using a novel multispectral FLIM endoscope and processed to generate widefield maps of biochemical and metabolic autofluorescence biomarkers of oral precancer and cancer. Statistical analyses applied to the quantified multispectral FLIM endoscopy based autofluorescence biomarkers indicated their potential to provide contrast between precancerous/cancerous vs. healthy oral epithelial tissue. To the best of our knowledge, this study represents the first demonstration of label-free biochemical and metabolic clinical imaging of precancerous and cancerous oral lesions by means of widefield multispectral autofluorescence lifetime endoscopy. Future studies will focus on demonstrating the capabilities of endogenous multispectral FLIM endoscopy as an image-guided surgical tool for positive margin detection during head and neck cancer resection surgery.

Abstract P4-13-03: Effect of intraoperative imprint cytology followed by frozen section for margin assessment in breast-conserving surgery

Abstract Purpose: In patients undergoing breast-conserving surgery (BCS) for breast cancer, the positive margin rate has reportedly reduced from 15%-50% to 6%-19% by the addition of intraoperative margin assessment (IMA). Previous reports have suggested that imprint cytology (IC) is superior to frozen section (FS) because the former can assess the entire circumference of surgical margins, although its precision is inferior to that of FS. In contrast, FS cannot evaluate the entire circumference of surgical margins and may result in sampling errors in the detection of positive margins. To date, reports on IMA have described only the single use of IC or FS. Therefore, the purpose of the present study was to elucidate the effect of IC followed by FS for IMA in BCS by comparing the positive margin rate with that of permanent section (PS). Patients and Methods: We enrolled a total of 522 cases which underwent BCS without neoadjuvant therapy between January 2013 and April 2019. The entire circumference of surgical margins was subjected to IC. Upon obtaining negative IC results, no other procedure was added for IMA. FS was only added for the cases with “positive” or “suspicious” IC results. We performed additional intraoperative excision for FS-positive sites of lesions and did not add any procedure for IMA. All margins were evaluated by postoperative PS after excision. We defined “PS positive” as the exposure of cancer cell for invasive ductal carcinoma and close margin less than 2 mm for non-invasive ductal carcinoma (DCIS) based on the Society of Surgical Oncology and American Society of Radiation Oncology guidelines (2014/2016). Cases diagnosed as IC positive but not subjected to additional intraoperative excision based on FS-negative findings were defined as “IC false positive.” We then compared the results of PS with those of IC and FS. In addition, we evaluated the association between clinicopathological factors and PS-positive or IC-false-positive diagnosis by univariate and multivariate analyses. Results: Of 522 cases, 136 (26.1%) were IC positive and 386 (73.9%) were IC negative. Among the 386 cases not subjected to FS for IMA because of IC-negative diagnosis, 11 (2.8%) were PS positive. In 47 (34.6%) of 136 IC-positive cases, additional intraoperative excision was unnecessary due to FS-negative diagnosis. Postoperative PS revealed that all of these 47 cases were PS negative. Although we performed additional intraoperative excision, 5 cases remained PS positive. There was no association between PS-positive diagnosis and clinicopathological factors. In univariate analysis, premenopausal status and DCIS significantly increased the IC-false-positive diagnosis risk (p &amp;lt; 0.0001 and p = 0.014, respectively). Multivariable analysis revealed that premenopause was a significant risk factor for IC-false-positive diagnosis (OR: 0.27, 95% CI: 0.13-0.56; p&amp;lt; 0.001). The overall positive margin rate on final pathology based on PS was 3.1% (16/522 cases). Conclusion: The proposed method is the best method to compensate for the individual weak points of IC and FS. Because upon finding margin-positive lesions on IC, FS were added to the lesions. Our findings indicate that the proposed strategy should be an optimal method for taking advantages of both IC and FS. As a result, the positive margin rate using our strategy was extremely low compared with that reported in previous studies. Citation Format: Tamaki Tamanuki, Maki Namura, Tomoyoshi Aoyagi, Tomoko Suwa, Shinichirou Shimizu, Hiroshi Matsuzaki. Effect of intraoperative imprint cytology followed by frozen section for margin assessment in breast-conserving surgery [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-13-03.

The smart approach: feasibility of lentigo maligna superficial margin assessment with hand-held reflectance confocal microscopy technology.

Lentigo maligna may be challenging to clear surgically. To evaluate feasibility of using superficial skin cuts as RCM imaging anchors for attaining negative surgical margins in lentigo maligna. Included patients presented with lentigo maligna near cosmetically sensitive facial structures. We evaluated, with hand-held-RCM, microscopic clearance of melanoma beyond its dermoscopically detected edges. Evaluated margins were annotated using shallow skin cuts. If a margin was positive at 'first-step' RCM evaluation, we sequentially advanced the margin radially outward at that segment by 2-mm intervals until an RCM-negative margin was identified. Prior to final surgical excision, we placed sutures at the outmost skin cuts to allow comparison of RCM and histopathological margin assessments. Primary outcome measure was histopathological verification that RCM-negative margins were clear of melanoma. The study included 126 first-step margin evaluations in 23 patients, median age 70 years (range: 43-91). Seventeen patients (74%) had primary in-situ melanoma and six (26%) invasive melanoma, mean thickness 0.3 mm (range 0.2-0.4 mm). Six cases (26%) showed complete negative RCM margins on 'first-step', 11 (48%) were negative at 'second-step', and four (17%) at 'third-step'. In two additional cases (9%), margins clearance could not be determined via RCM due to widespread dendritic cells proliferation. The RCM-negative margins in all 21 cases proved clear of melanoma on histopathology. Of the 15 cases that returned at 1-year follow-up, none showed any residual melanoma on dermoscopic and RCM examinations. Interobserver reproducibility showed fair agreement between bedside RCM reader and blinded remote-site reader, with Spearman's rho of 0.48 and Cohen's kappa of 0.43; using bedside reader as reference, the remote reader's sensitivity was 92% and specificity 57% in positive margin detection. Margin mapping of lentigo maligna with hand-held-RCM, using superficial skin cuts, appears feasible. This approach needs validation by larger studies.

The cost of accuracy: A budget impact analysis of whole-mount histopathology processing for patients with breast cancer undergoing breast conservation

BackgroundObtaining precise histopathologic detail for breast lumpectomy specimens is challenging due to extensive sampling and loss of 3-dimensional conformation with conventional methods. Whole-mount (WM) technique is a method of serial pathologic sectioning designed to maximize cross-sectional visualization, and enhance evaluation of margin status. MethodsA decision analytic model was used to create a budget impact analysis comparing costs and outcomes for conventional processing and WM technique for breast lumpectomy specimens. Outcomes included additional operations, time required for processing and pathology interpretation, and the number of slides produced. Cost trade-offs were compared using incremental cost-effectiveness ratios, and a 3-year cost forecast was generated to estimate institutional expenditures required for variable adoption of the WM process. Deterministic and probabilistic sensitivity analyses were performed. Costs are reported in Canadian dollars and are 2014 appraisals. ResultsWM technique has a higher mean cost per patient ($3218) compared to conventional processing ($1414) and generates 19% more operations due to detection of positive margins. The number of pathology slides produced and pathologist hours required for interpretation were reduced with WM technique. WM costs an additional $9495 per extra operation completed but is forecasted to save approximately 1200 pathologist work hours over 3 years. The model was robust to tested ranges and most sensitive to changes in positive margin prevalence. ConclusionThe initiation of routine WM processing for breast lumpectomy specimens is costly. However, favourable tradeoffs in diagnostic accuracy and histopathologic efficiency underpin the need to deliberately consider the adoption of WM technique.

Structured Illumination Microscopy and a Quantitative Image Analysis for the Detection of Positive Margins in a Pre-Clinical Genetically Engineered Mouse Model of Sarcoma.

Intraoperative assessment of surgical margins is critical to ensuring residual tumor does not remain in a patient. Previously, we developed a fluorescence structured illumination microscope (SIM) system with a single-shot field of view (FOV) of 2.1×1.6 mm (3.4 mm2) and sub-cellular resolution (4.4 μm). The goal of this study was to test the utility of this technology for the detection of residual disease in a genetically engineered mouse model of sarcoma. Primary soft tissue sarcomas were generated in the hindlimb and after the tumor was surgically removed, the relevant margin was stained with acridine orange (AO), a vital stain that brightly stains cell nuclei and fibrous tissues. The tissues were imaged with the SIM system with the primary goal of visualizing fluorescent features from tumor nuclei. Given the heterogeneity of the background tissue (presence of adipose tissue and muscle), an algorithm known as maximally stable extremal regions (MSER) was optimized and applied to the images to specifically segment nuclear features. A logistic regression model was used to classify a tissue site as positive or negative by calculating area fraction and shape of the segmented features that were present and the resulting receiver operator curve (ROC) was generated by varying the probability threshold. Based on the ROC curves, the model was able to classify tumor and normal tissue with 77% sensitivity and 81% specificity (Youden’s index). For an unbiased measure of the model performance, it was applied to a separate validation dataset that resulted in 73% sensitivity and 80% specificity. When this approach was applied to representative whole margins, for a tumor probability threshold of 50%, only 1.2% of all regions from the negative margin exceeded this threshold, while over 14.8% of all regions from the positive margin exceeded this threshold.

Abstract P1-16-06: Margin Probe device is able to reduce re-excision rate of breast conserving surgery in invasive and pre-invasive breast cancer independent from any patient or tumor related factors

Abstract Background: A positive margin status after breast conserving surgery (BCS) is one of the strongest predictors of local recurrence of intraductal and invasive carcinoma. As much as 20-50% of all patients with BCS need to undergo a second operation in order to receive free margins. In this study we tested the clinical performance of Margin Probe (Dune Medical Devices), a novel device for intraoperative margin evaluation. Methods: A prospective clinical trial was performed: The device was applied to 150 lumpectomy specimen from consecutive patients with BCS treated during the first three months in 2013. The re-excision rate was compared to the re-excision rate of a historical group of 156 patients treated with BCS during the first three months in 2012, without the application of the device. We analyzed whether Margin Probe is affected by tumor morphology, grading, size of the tumor, breast density, age, body-mass-index or the use of wire-marker. Results: Due to the application of Margin Probe the re-excision rate decreased significantly by 51% from 39.7% to 14.6%. In the subgroup of intraductal carcinoma (DCIS) the re-excision rate was reduced about two thirds from 66.7% to 23.1%. In the subgroup of invasive lobular carcinomas the re-excision rate decreased from 37.0% to 19.0%. Margin Probe results are not affected by grading, tumor size, breast-density, age, body-mass-index or wire-marker application. Conclusion: Margin Probe is an effective tool for detection of positive margins during BCS and significantly decreases the re-excision rate. It is not limited to invasive carcinoma but also detects involved margins in DCIS as well as in invasive lobular carcinoma. It does not interfere with any of the factors we examined. Citation Format: Jens Uwe Blohmer, Julia Tanko, Ragna Voelker, Julia de Grahl, Jessica Gross. Margin Probe device is able to reduce re-excision rate of breast conserving surgery in invasive and pre-invasive breast cancer independent from any patient or tumor related factors [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-16-06.

366 IS PARTIAL SAMPLING OF A RADICAL PROSTATECTOMY SPECIMENS ASSOCIATED WITH MISSING OF POSITIVE MARGINS OR EXTRAPROSTATIC EXTENSIONS?

You have accessJournal of UrologyProstate Cancer: Staging II1 Apr 2012366 IS PARTIAL SAMPLING OF A RADICAL PROSTATECTOMY SPECIMENS ASSOCIATED WITH MISSING OF POSITIVE MARGINS OR EXTRAPROSTATIC EXTENSIONS? Viacheslav Iremashvili, Soum Lokeshwar, Merce Jorda, Murugesan Manoharan, Saleem A. Umar, and Mark S. Soloway Viacheslav IremashviliViacheslav Iremashvili Miami, FL More articles by this author , Soum LokeshwarSoum Lokeshwar Miami, FL More articles by this author , Merce JordaMerce Jorda Miami, FL More articles by this author , Murugesan ManoharanMurugesan Manoharan Miami, FL More articles by this author , Saleem A. UmarSaleem A. Umar Miami, FL More articles by this author , and Mark S. SolowayMark S. Soloway Miami, FL More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.428AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The pathologic stage and surgical margin status of a radical prostatectomy (RP) specimen may directly impact subsequent patient management. The aim of our study was to determine if different methods of partial sampling affect the accuracy of detection of positive margins (PMs) and/or extraprostatic extensions (EPEs). METHODS Between January 1992 and May 2011 1,975 patients underwent open RP performed by one surgeon. We identified 808 cases that had either PM or EPE or both. In all cases a 2 mm apical margin was obtained from the most distal part of the prostate. The gland was than step-sectioned at 3-4-mm intervals in transverse planes into separate blocks according to the Stanford protocol. 697 of our cases had a diagram describing the outline of cancer areas as well as location of PM and EPE in each of the blocks. Using these diagrams we analyzed the potential outcomes of four published methods of partial sampling (Table 1). The rates of PM § and EPEs that could have been identified using each of these techniques were compared to the actual rates obtained by entire sampling. Table 1. Studied methods of partial prostate sampling No. Description Publication 1 Three “representative” sections including apical, mid and basal parts of the gland Samaratunga H, et al. Mod Pathol. 2011; 24: 6-15. 2 Alternate sections Cohen MB, et al. Am J Clin Pathol. 1994; 101: 250-2. 3 Alternate sections representing the posterior aspect of the gland in addition to one of the mid-anterior Salem S, et al. J Urol. 2010; 184: 1334-40. 4 Every section representing the posterior aspect of the gland in addition to one of the mid-anterior, supplemented by additional sections based on tumor size Sehdev AES, et al. Hum Pathol. 2001; 32: 494-9. RESULTS Of 697 RP specimens, only PMwas identified in 387 (56%) cases, only EPE in 136 (20%), and both were identified in 174 (25%). All alternative sampling methods missed a significant number of PM § and/or EPEs (p<0.001 (McNemar test) for all pairs of comparison), however the numbers of missed cases varied considerably (Figure 1) among the studied techniques. The lowest rates were noted for method 4, which would have missed only 6% of PM § and 7% of EPEs. CONCLUSIONS Most methods of partial sampling miss considerable proportion of PM § and/or EPEs. The latter was particularly dependent on the sampling technique. The only method which missed less than 10% of PM §/EPEs found on entire sampling was the technique described by Sedhev et al. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e150 Peer Review Report Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Viacheslav Iremashvili Miami, FL More articles by this author Soum Lokeshwar Miami, FL More articles by this author Merce Jorda Miami, FL More articles by this author Murugesan Manoharan Miami, FL More articles by this author Saleem A. Umar Miami, FL More articles by this author Mark S. Soloway Miami, FL More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

A device for real-time, intraoperative margin assessment in breast-conservation surgery (BCS) of ductal carcinoma in situ (DCIS).

e11080 Background: A sufficient margin assessment when excising a DCIS of the breast is difficult. Frozen section is unreliable and intraoperative radiography of the specimen gives only information about the size of the noticed lesion or the microcalcifications. This trial was conducted to study the benefit of a novel device (MarginProbe, Dune Medical Devices. Ltd.) in intraoperative margin assessment for BCS of DCIS and the associated reduction in reoperations. Methods: A multicenter, single arm study was conducted to determine the added benefit of the device use. The device was used as an adjunctive tool to the current practice. The surgeon received real time device output and reacted surgically intraoperatively. Based on the permanent histology report outcome, the added benefit of device use is demonstrated. Analyzed were the first 15 pts. enrolled in our institution (Sept. 2009–Jan. 2010). This preliminary analysis was done because of the excellent results. Results: Patients who benefit from MarginProbe were analyzed (8/15). Device use was associated with improved correct surgical reaction, defined as patients in which all histologically detected positive margins on the main specimen were identified by the device and resected intraoperatively. In 50 % (4/8, 50%) a repeat operation was avoided, in 2 pts. the device did not detect all positive margins (2/8, 25%) and two patients turned out to have invasive cancer (2/25%). Conclusions: Intraoperative use of the MarginProbe for positive margin detection is safe, fast and effective in BCS and decreases the rate of repeat operations by 50%. No significant financial relationships to disclose.

A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery

A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery

A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery

Background This randomized, double-arm trial was designed to study the benefit of a novel device (MarginProbe, Dune Medical Devices, Caesarea, Israel) in intraoperative margin assessment for breast-conserving surgery (BCS) and the associated reduction in reoperations. Methods In the device group, the probe was applied to the lumpectomy specimen and additional tissue was excised according to device readings. Study arms were compared by reoperation rates and by correct surgical reaction confirmed by histology. Results Three hundred patients were enrolled. Device use was associated with improved correct surgical reaction, defined as additional re-excision in all histologically detected positive margins, with tumor within 1 mm of inked margin. The repeat lumpectomy rate was significantly reduced by 56% in the device arm: 5.6% versus 12.7% in the control arm. There were no differences in excised tissue volume or cosmetic outcome. Conclusions Intraoperative use of the MarginProbe for positive margin detection is safe and effective in BCS and decreases the rate of repeat operations.

A device for real-time, intraoperative margin assessment in breast-conservation surgery

Background This trial was designed to study performance of a novel handheld probe (Dune Medical Devices, Caesarea, Israel) in intraoperative detection of positive margins and its potential benefit toward minimizing the positive margin rate. Methods The probe was intraoperatively applied to 57 lumpectomy specimens. Surgeons were blinded to device output, and surgical decisions were not affected by probe data. Probe readings were compared with histological analysis per margin and per patient. Results Nineteen of 22 (86%) pathology-positive patients were intraoperatively detected with device use. Per-margin sensitivity was .71, and specificity was .68, maintained within a range of positive margin definitions (0–.4 cm). Conclusions The device is an effective tool for intraoperative detection of positive margins with the potential for significant positive margin rate reduction.