The American Society of Breast SurgeonsA prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery
Section snippets
Study design and patient selection
Subjects were enrolled at 11 institutions in a prospective, multicenter, randomized, controlled, institutional review board–approved study. All patients were scheduled to undergo BCS for treatment of invasive and/or pre-invasive breast cancer. Patients were excluded if they had received neoadjuvant chemotherapy, had prior surgical procedures or implants in the ipsilateral breast, or were participating in other clinical trials that might interfere with the protocol or device measurements. All
Results
From November 2006 through November 2007, 300 patients were enrolled in the study, 149 and 151 in the “device” and “control” arms, respectively. Of these, 7 patients did not fit the inclusion/exclusion criteria for the study or had protocol violations and were excluded (1 received neoadjuvant therapy, 1 underwent a mastectomy as the primary procedure, 2 had prior surgery in the same quadrant, 1 was not preoperatively diagnosed with malignancy, and in 2 patients the device was not applied to all
Comments
This prospective, randomized, controlled study demonstrates the safety and effectiveness of a new device for real-time intraoperative margin assessment. After excision of the main lumpectomy specimen during BCS, the surgeon must decide whether additional tissue needs to be re-excised from the lumpectomy cavity, and if so, from which aspects. In this study, patients were randomized at this point of the procedure to 2 study arms, with or without device use. In both arms surgeons equally used
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Cited by (130)
New Technology for the Breast Surgeon
2023, Surgical Clinics of North AmericaComparison of “click-to-sense” assay with frozen section analysis using simulated surgical margins in breast cancer patients
2022, European Journal of Surgical OncologyCitation Excerpt :Our previous study has shown that breast cancers generally show the strong red-staining by the CTS assay but, in a rare instance, the well-differentiated DCIS components might suffer from a low oxidative stress and are not detected by the CTS assay. Recently, radio-frequency spectroscopy (MarginProbe® device [22,23]) and bioimpedance spectroscopy (ClearEdge™ device [24]) have been shown to be useful for real-time intraoperative assessment of the surgical margins in BCS in clinical trials. In addition, [18F] FDG flexible autoradiography (FAR) imaging with the LightPath® Imaging System was evaluated in its feasibility of intraoperative assessment of the surgical margins in BCS in the multi-centre study [25].
The efficiency of MarginProbe in detecting positive resection margins in epithelial breast cancer following breast conserving surgery
2022, European Journal of Surgical OncologyRapid Assessment of Resection Margins During Breast Conserving Surgery Using Intraoperative Flow Cytometry
2021, Clinical Breast Cancer
Supported by Dune Medical Devices, Caesarea, Israel.