Geburtshilfe Frauenheilkd 2018; 78(10): 250
DOI: 10.1055/s-0038-1671518
Poster
Freitag, 02.11.2018
Senologie III
Georg Thieme Verlag KG Stuttgart · New York

Successful intraoperative margin assessment in DCIS and invasive breast cancer with diffusion-weighted MRI using the ClearSight™ system

M Thill
1  Agaplesion Markus Krankenhaus, Klinik für Gynäkologie und Geburtshilfe, Frankfurt, Deutschland
,
S Aulmann
2  OptiPath, Frankfurt, Deutschland
,
V van Haasteren
1  Agaplesion Markus Krankenhaus, Klinik für Gynäkologie und Geburtshilfe, Frankfurt, Deutschland
,
L Traub
1  Agaplesion Markus Krankenhaus, Klinik für Gynäkologie und Geburtshilfe, Frankfurt, Deutschland
,
J Nölke
1  Agaplesion Markus Krankenhaus, Klinik für Gynäkologie und Geburtshilfe, Frankfurt, Deutschland
,
I Szwarcfiter
3  Clearcut, Rehovot, Israel
,
M Shapiro
3  Clearcut, Rehovot, Israel
,
A Schön
3  Clearcut, Rehovot, Israel
,
K Kelling
1  Agaplesion Markus Krankenhaus, Klinik für Gynäkologie und Geburtshilfe, Frankfurt, Deutschland
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Publikationsverlauf

Publikationsdatum:
20. September 2018 (online)

 

Aim:

Aim of our study is to evaluate the performance of the ClearSight™ system (ClearCut Medical, Ltd.) in assessing surgical margins for DCIS and IBC in breast conserving surgery (BCS).

Material and methods:

The ClearSight™ system utilizes a diffusion-weighted-imaging (DWI) protocol to create 2D surface maps showing T2*, a MR parameter related to the tissue's apparent diffusion coefficient (ADC), with a depth penetration of 1 – 1.5 mm. ADC is a highly accurate differentiator for malignant versus benign tissue.

From November 2017 a prospective, blinded Post Marketing study (N = 70), evaluating the performance of the ClearSight™ system is being conducted in the Breast Centre at the Agaplesion Markus Krankenhaus, Frankfurt, Germany. After standard evaluation with ultrasound and/or X-ray, the specimens are being scanned with the ClearSight™ system and compared with the final histopathology results on a margin per margin bases.

Results:

Till now margins from 25 patients were analysed. Pursuant to the BCS, 146 margins were scanned by the ClearSight™ system. In comparison with the pathology findings this results in a sensitivity of 75% (95% CI: 56 – 94%), and specificity 86% (95% CI: 80%-92%). The re-operation rate was 36% (9/25), however, the ClearSight™ found 8/9 (89%) margins be positive. If the scan results would had been unblinded to the surgeon only 1/25 would have required re-excision surgery, resulting in a theoretical re-operation rate of 4%.

Conclusion:

Despite the limited sample size of this preliminary analysis, the initial results suggest that the technology promises to reduce re-excision rates well below the currently observed standard.