Start of the Magnetic Resonance Outcome (MRO) study to evaluate the ClearCoast™ MRI system
The ClearCoast™ MRI system makes it possible to perform precise intraoperative margin evaluation during breast-conserving surgery – often eliminating the need for the patient to undergo a second operation. In the MRO study, launched in June 2021, surgeons are able for the first time to evaluate the tissue margin during the operation. The aim: to reduce the rate of second operations by 80 percent.
Being able to evaluate the margin quickly and precisely during the operation helps the surgeon to make sure the tumour is completely removed, while at the same time conserving as much of the healthy surrounding tissue as possible. However, with the methods used to date, a second procedure – either a follow-up tumour resection or, in the worst case, a mastectomy – is unavoidable in 15 to 30 percent of cases.1
It’s a different story with the diffusion-weighted MRI technology used in the ClearCoast™ system: this method enables quick and precise evaluation of the excised tissue, directly during the operation. This allows the surgeon to identify positive margins immediately, without any need to consult a radiologist. If a follow-up tumour resection is required, it can be performed straight away, as an extension of the initial operation. Previous studies of the ClearCoast™ system indicate that it has the potential to reduce the rate of repeat tumour resections by up to 80 percent.2
The current study, launched on 22 June 2021 at the Agaplesion Markus Hospital in Frankfurt am Main under the direction of Professor Dr. med. Marc Thill, aims to provide verifiable data confirming the efficacy of the ClearCoast™ system. As the study was set to begin, Thill summarised the aim: “The innovative ClearCoast™ system represents a milestone in breast conserving surgery. It delivers equal benefit both to the health system, and directly to the patient. I will be delighted if, through this study, we can provide evidence of the benefits of this system.” The ClearCoast™ system is manufactured by ClearCut Medical Ltd., who is also the study sponsor. pfm medical is the exclusive sales partner in Europe.
1 Benjamin W. Maloney, David M. McClatchy, Brian W. Pogue, Keith D. Paulsen, Wendy A. Wells, Richard, J. Barth, Jr.“Review of methods for intraoperative margin detection for breast conserving surgery,” J. Biomed. Opt. 23(10), 100901 (2018), doi: 10.1117/1.JBO.23.10.100901
2 Thill M. et al., Successful Intraoperative Margin Assessment In Ductal Carcinoma In-Situ and Invasive Breast Cancer With Diffusion Weighted MRI Using ClearSight™ System 62. DGGG, Berlin 31.10.-03.11.11.2018