Breast cancer diagnostics: Diffusion-weighted MRI for intraoperative assessment of the surgical margin during breast conserving surgery
The methods currently used for intraoperative assessment of the surgical margin have thus far been unable to prevent the necessity for repeated surgeries or even mastectomy in 15% to 35% of cases.1
However, the ClearCoast™ MRI System represents clear progress in intraoperative assessment of the surgical margin as part of breast-conserving surgery. The proven technology of the ClearCoast™ MRI System helps surgeons make a quick and precise intraoperative assessment of the surgical margin, and remove the tumour while preserving as much of the healthy surrounding tissue as possible.
The diffusion-weighted MRI technology of the innovative ClearCoast™ MRI System enables precise intraoperative analysis of the excised tissue, allowing positive margins to be identified during the procedure. Therefore, any necessary additional resection can already be performed during the initial operation. This means that re-excisions can be reduced by up to 80%.2
Method of operation
The ClearCoast™ MRI System is an in vitro diagnostic device that allows surgeons to make a quick and precise intraoperative assessment of the surgical margin. This allows them to remove the tumour while preserving as much of the healthy tissue as possible.
The System enables precise analysis of the excised tissue. Positive margins can thus still be identified during the operations. Translating the scan results into a colour code makes it easy to interpret a 2D colour map. Any re-excision that may be necessary can be performed immediately; the need for subsequent surgery is reduced significantly.
Thanks to its intuitive operation, the ClearCoast™ MRI System can be easily integrated in existing workflows. It is mobile around the operating theatre and can be placed in different operating rooms.
During imaging with the in vitro diagnostic device no radiation exposure occurs for the patient and no systemic media are required. No radiological or histopathological expertise is required to use the System. Trained staff can use it easily.
Easy operation and simple interpretation
The intuitive and easy operation together with the simple interpretation of the colour-coded results eliminate the need for the user to have detailed technical, histopathological or radiological expertise. Trained, non-medical staff, can operate the ClearCoast™ MRI System.
Translation of ClearCoast™ output image; reddish pixels= high probability of malignant tissue (right)
Fewer follow-up operations
The ClearCoast™ MRI System offers surgeons increased confidence in detecting positive margins (R1 situations) during the initial breast-conserving surgery. As a result, the number of repeated surgeries can be reduced by up to 80%.2
Improved quality of life
A reduction of repeated surgeries can be a significant relief for the patients - both physically and psychologically. General surgical risks as well as worries and fear can be reduced accordingly.1
The necessary adjuvant therapies can be introduced without delay.3
In 15% to 35% of breast-conserving surgery cases a re-excision is required.3 Every follow-up operation that is saved reduces costs and freed-up operating theatre capacity can be put to use elsewhere.
Vacuum technology removes air from the ClearCoast™ Tissue Container. This puts the tissue in direct contact with the MRI scanning surface. Blind spots caused by air bubbles are reduced. Aids to fix the tissue are redundant.
Better aesthetic outcome
The aesthetic outcome can be one of the most important aspects of breast-conserving surgery for many patients.4 An accurate intraoperative assessment of the margin can allow the surgeon to make the excision with as little safety distance from the tumour as possible. Every follow-up intervention saved also has a positive influence on the result in itself.
The ClearCoast™ is an innovative, mobile MRI system based on diffusion-weighted MRI (DW-MRI), which measures the mobility (diffusion speed) of water molecules on the tissue surface. The histological properties of the tissue determine the diffusion speed. Malignant tissue has a higher cellularity, which restricts the diffusion speed of water between the cells. As such, diffusion-weighted MRI offers an ideal way to differentiate between physiological and pathologically altered (e.g. malignant) tissue - and without the administration of contrast media.5
low cellularity = high diffusion speed
high cellularity = low diffusion speed
- Quick margin assessment: Process time comparable to - or less than - frozen section procedure analysis.
- Mobile MRI, which offers the advantages of MRI technology in any surgical environment.
- Shielded system without ionising radiation. No additional apparatus, equipment or a special room are needed and any precautions or measurements required. In addition, no precautions or measurements are necessary.
- The use of contrast media is not necessary. The associated potential for allergic reactions or other side-effects can be avoided and patient preparation time can be reduced.
- Preserve the integrity and quality of the tissue sample so that the histopathological assessment can subsequently be carried out unimpeded.2
To use the ClearCoast™ MRI System, the ClearCoast™ Tissue Containers are required. The applied vacuum of the excidate allows a rapid scan of all six sides of the tumour.
ClearCoast™ MRI System
- Method of operation: Magnetic resonance diffusion measurement
- Dimensions: W 68.5* x H 168.2 x D 105.0 cm
- Scan resolution: 4 x 3.5 mm
- Scan surface diameter: max. 88 mm
- Input voltage: 100 - 240 V, 50 - 60 Hz
- Weight: 275 kg
*with folded shelf 113.5 cm
ClearCoast™ Tissue Container
- Patient-specific consumable materials
- Tissue volume: max. 200 ml
- Tissue-specimen diameter: max. 7 cm
- Weight: 80 g
Maloney, B. et al., Review of methods for intraoperative margin detection for breast conserving surgery, J Biomed Opt. 2018, 23(10): 1-19
Thill, M. et al., 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, J Surg Oncol. 2022, 125(3): 361-368. doi: 10.1002/jso.26721. Epub 2021 Nov 1. PMID: 34724205
Walijee, J. et al., Predictors of re-excision among women undergoing breast-conserving surgery for cancer, Ann Surg Oncol. 2008; 15(5): 1297-303
Catsman, C. et al., The COSMAM TRIAL a prospective cohort study of quality of life and cosmetic outcome in patients undergoing breast conserving surgery, BMC Cancer. 2018, 18(1): 456
Guo, Y. et al., Differentiation of clinically benign and malignant breast lesions using diffusion-weighted imaging, J Magn Reson Imaging. 2002; 16(2): 172–178
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