Analysis of the Impact of Intraoperative Margin Assessment with Adjunctive Use of MarginProbe versus Standard of Care on Tissue Volume Removed

Rivera, Ronald; Holmes, Dennis R.; Tafra, Lorraine

doi:10.1155/2012/868623

Cited by 13 publications

(14 citation statements)

References 10 publications

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“…Pathological findings of involved or close margins require follow up re-excision surgery within days to weeks of the original excision, resulting in increased risk of morbidity, undue patient stress, increased cost to both the patient and healthcare system, as well as delay of adjuvant therapy, all negatively affecting patient outcomes 2 - 6 . Technologies currently deployed in the clinic to improve margin detection include frozen section analysis (FSA) 7 , touch prep cytology 8 , specimen radiography 9 , specimen ultrasound 10 , and radiofrequency spectroscopy 11 . Each technique has shown improvement in tumor re-excision rates, but sensitivity and specificity performance has been mixed and lengthy tissue processing procedures in some cases limit translation to the clinic 7 , 8 , 12 - 20 .…”

Section: Introductionmentioning

confidence: 99%

Optimizing fresh specimen staining for rapid identification of tumor biomarkers during surgery

Barth¹,

Schaefer²,

Rossi³

et al. 2017

Theranostics

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Rationale: Positive margin status due to incomplete removal of tumor tissue during breast conserving surgery (BCS) is a prevalent diagnosis usually requiring a second surgical procedure. These follow-up procedures increase the risk of morbidity and delay the use of adjuvant therapy; thus, significant efforts are underway to develop new intraoperative strategies for margin assessment to eliminate re-excision procedures. One strategy under development uses topical application of dual probe staining and a fluorescence imaging strategy termed dual probe difference specimen imaging (DDSI). DDSI uses a receptor-targeted fluorescent probe and an untargeted, spectrally-distinct fluorescent companion imaging agent topically applied to fresh resected specimens, where the fluorescence from each probe is imaged and a normalized difference image is computed to identify tumor-target distribution in the specimen margins. While previous reports suggested this approach is a promising new tool for surgical guidance, advancing the approach into the clinic requires methodical protocol optimization and further validation.Methods: In the present study, we used breast cancer xenografts and receiver operator characteristic (ROC) curve analysis to evaluate a wide range of staining and imaging parameters, and completed a prospective validation study on multiple tumor phenotypes with different target expression. Imaging fluorophore-probe pair, concentration, and incubation times were systematically optimized using n=6 tissue specimen replicates per staining condition. Resulting tumor vs. normal adipose tissue diagnostic performance were reported and staining patterns were validated via receptor specific immunohistochemistry colocalization. Optimal staining conditions were tested in receptor positive and receptor negative cohorts to confirm specificity.Results: The optimal staining conditions were found to be a one minute stain in a 200 nM probe solution (area under the curve (AUC) = 0.97), where the choice of fluorescent label combination did not significantly affect the diagnostic performance. Using an optimal threshold value determined from ROC curve analysis on a training data set, a prospective study on xenografts resulted in an AUC=0.95 for receptor positive tumors and an AUC = 0.50 for receptor negative (control) tumors, confirming the diagnostic performance of this novel imaging technique.Conclusions: DDSI provides a robust, molecularly specific imaging methodology for identifying tumor tissue over benign mammary adipose tissue. Using a dual probe imaging strategy, nonspecific accumulation of targeted probe was corrected for and tumor vs. normal tissue diagnostic potential was improved, circumventing difficulties with ex vivo tissue specimen staining and allowing for rapid clinical translation of this promising technology for tumor margin detection during BCS procedures.

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Section: Introductionmentioning

confidence: 99%

Optimizing fresh specimen staining for rapid identification of tumor biomarkers during surgery

Barth¹,

Schaefer²,

Rossi³

et al. 2017

Theranostics

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“…In Nordeuropa und Nordamerika beträgt die Nachresektionsrate und sekundäre Mastektomierate nach brusterhaltender Operation bis zu 30-40%, selbst in Ländern mit einer etablierten Struktur der Brustzentren wie den Niederlanden und Großbritannien [21,22,29].…”

Section: Operationsplanung Zur Reduktion Der Nachresektionsrate Und Lunclassified

Operative Therapie des Mammakarzinoms

Blohmer

2015

Onkologe

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Die Entfernung des Mammakarzinoms ist zunächst der erste therapeutische Schritt der Ärzte und der Patientin. Auch wenn heute viele Patientinnen mit einem Mammakarzinom auch aus Gründen der In-vivoChemo-oder Hormontherapie-Sensitivitätstestung zunächst medikamentös behandelt werden, wird nahezu jede Patientin wegen eines Mammakarzinoms im Verlauf der multimodalen Therapie operiert. Wenn innerhalb von Studien keine Operation, sondern lediglich eine medikamentöse Behandlung und eine Strahlentherapie durchgeführt wurden, war die Lokalrezidivrate bei diesem Vorgehen höher als bei den operierten Patientinnen [27]. Das Mammakarzinom muss also operiert werden.

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“…Established IMA techniques include frozen‐section analysis, cytology, intraoperative ultrasonography and specimen radiography, all of which have unique limitations; no single IMA technique has gained universal adoption to date. Emerging technologies such as MarginProbe® (DUNE Medical Devices, Alpharetta, Georgia, USA) have been found to reduce reoperation rates to 14·1 per cent. The iKnife (Waters Corporation, Milford, Massachusetts, USA), is a novel mass spectrometric method that allows intraoperative analysis of breast tissue types and thus resection margin status in vivo by interpretation of cellular chemical components.…”

Section: Discussionmentioning

confidence: 99%

Patient-level costs in margin re-excision for breast-conserving surgery

Grant

Al-Khudairi

John

et al. 2019

Journal of British Surgery

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Background: High rates of reoperation following breast-conserving surgery (BCS) for positive margins are associated with costs to healthcare providers. The aim was to assess the quality of evidence on reported re-excision costs and compare the direct patient-level costs between patients undergoing successful BCS versus reoperations after BCS. Methods: The study used data from women who had BCS with or without reoperation at a single institution between April 2015 and March 2016. A systematic review of health economic analysis in BCS was conducted and scored using the Quality of Health Economic Studies (QHES) instrument. Financial data were retrieved using the Patient-Level Information and Costing Systems (PLICS) for patients. Exchange rates used were: US $1 = £0⋅75, £1 = €1⋅14 and US $1 = €0⋅85. Results: The median QHES score was 47 (i.q.r. 32⋅5-79). Only two of nine studies scored in the upper QHES quartile (score at least 75). Costs of initial lumpectomy and reoperation were in the range US $1234-11786 and $655-9136 respectively. Over a 12-month interval, 153 patients had definitive BCS and 59 patients underwent reoperation. The median cost of reoperations after BCS (59 patients) was £4511 (range 1752-18 019), representing an additional £2136 per patient compared with BCS without reoperation (P < 0⋅001). Conclusion: The systematic review demonstrated variation in methodological approach to cost estimates and a paucity of high-quality cost estimate studies for reoperations. Extrapolating local PLICS data to a national level suggests that getting BCS right first time could result in substantial savings.

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Analysis of the Impact of Intraoperative Margin Assessment with Adjunctive Use of MarginProbe versus Standard of Care on Tissue Volume Removed

Cited by 13 publications

References 10 publications

Optimizing fresh specimen staining for rapid identification of tumor biomarkers during surgery

Optimizing fresh specimen staining for rapid identification of tumor biomarkers during surgery

Operative Therapie des Mammakarzinoms

Patient-level costs in margin re-excision for breast-conserving surgery

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