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

https://doi.org/10.1016/j.amjsurg.2008.06.024Get rights and content

Abstract

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.

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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    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].

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Supported by Dune Medical Devices, Caesarea, Israel.

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