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Clinical Trial
. 2022 Mar;125(3):361-368.
doi: 10.1002/jso.26721. Epub 2021 Nov 1.

Magnetic resonance imaging system for intraoperative margin assessment for DCIS and invasive breast cancer using the ClearSight™ system in breast-conserving surgery-Results from a postmarketing study

Marc Thill  1 , Iris Szwarcfiter  2 , Katharina Kelling  1 , Viviane van Haasteren  1 , Eyal Kolka  2 , Josefa Noelke  1 , Zachi Peles  2 , Moshe Papa  3   4 , Sebastian Aulmann  5 , Tanir Allweis  6   7
Affiliations
Clinical Trial

Magnetic resonance imaging system for intraoperative margin assessment for DCIS and invasive breast cancer using the ClearSight™ system in breast-conserving surgery-Results from a postmarketing study

Marc Thill et al. J Surg Oncol. 2022 Mar.

Abstract

Background and objectives: Breast-conserving surgery (BCS) is followed by reoperations in approximately 25%. Reoperations lead to an increased risk of infection and wound healing problems as well as a worse cosmetic outcome. Several technical approaches for an intraoperative margin assessment to decrease the reoperation rate are under evaluation, some of them are still experimental.

Methods: A prospective single-arm post-marketing study with 60 patients undergoing BCS for ductal carcinoma in situ (DCIS) and invasive breast cancer was conducted. The specimen was intraoperatively examined by the ClearSight™ system, a mobile magnetic resonance imaging system that is based on a diffusion-weighted imaging protocol. However, the results were blinded to the surgeon.

Results: The ClearSight™ system was performed for both ductal and lobular breast cancer and DCIS, with a sensitivity of 0.80 (95% confidence interval [CI]: 0.44-0.96) and a specificity of 0.84 (95% CI 0.72-0.92), with an overall diagnostic accuracy of 80%.

Conclusion: Had the ClearSight™ been known to the surgeon intraoperatively, the reoperation rate would have been reduced by 83% for invasive carcinoma, from 10% to 2%, and 50% for DCIS, from 30% to 15% reoperations. A trial designed to examine the impact on reoperation rates is currently ongoing.

Keywords: diffusion weighted; lumpectomy; re-excision rate; surgical margins.

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Conflict of interest statement

Marc Thill received honoraria for advisory boards from ClearCut, Norgine, Neodynamics, pfm medical, RTI Surgical, and Sysmex; manuscript support from ClearCut and pfm medical; travel reimbursement from Medtronic, Norgine, pfm Medical, and RTI Surgical; and lecture honoraria from Medtronic, pfm medical, and RTI Surgical. Iris Szwarcfiter is a Clear‐Cut employee and has a financial interest in the company. Katharina Kelling received honoraria for advisory boards from pfm medical. Eyal Kolka is a Clear‐Cut's Innovator and has a financial interest in the company. Zachi Peles is a Clear‐Cut employee and has a financial interest in the company. Moshe Papa is a Clear‐Cut consultant and has a financial interest in the company. Vivane van Haasteren, Josefa Noelke, Sebastian Aulmann, and Tanir Allweis declare that there are no conflict of interests.

Figures

Figure 1
Figure 1
ClearSight™ system scans: (1) Optical image of the fresh breast tissue with a defined scanned area (white). In red are marked the highest T2* values within the tissue. (2) A 2D color‐coded magnetic resonance map (T2* values). 2D, two dimensional; ANT, anterior; INF, inferior; LAT, lateral; MED, medial; SUP, superior
Figure 2
Figure 2
Receiver operating characteristics (ROC) curve of ClearSight™ performance (all histological subtypes). ROC curve of two different datasets: (1) complete dataset containing all samples (squares) and (2) samples scanned within 1 h from specimen excision (circles)
See this image and copyright information in PMC

Comment in

References

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