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 tumour 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 ClearCoast™ MRI 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 necessary re-excision 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.

The ClearCoast™ MRI system is an in vitro diagnostic device. Therefore, no radiation exposure occurs for the patient during imaging and no systemic media are required. No radiological or histopathological expertise is required to use the ClearCoast™ MRI system. Trained staff can use the ClearCoast™ MRI system easily.

Benefits

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.

Photographic image of the excised inked tumor (left)
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

Cost savings

In 15% to 35% of breast-conserving tumour 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.

Clear vision

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.

Technology

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

Physiological tissue:
low cellularity = high diffusion speed
Malignant tissue:
high cellularity = low diffusion speed

Details

  • Quick margin assessment: Process time comparable to – or less than - frozen section procedure analysis.
  • Mobile and compact MRI that offers the advantages of MRI technology in any surgical environment while saving space and adapting to existing workflows.
  • Shielded system without ionising radiation. No additional apparatus, equipment or a special room are needed and any precautions or measurements required.
  • 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.

Operation

1. Place the tissue in the ClearCoast™ tissue container with the area to be scanned facing the glass.
2. Close the lid.
3. Slide the ClearCoast™ tissue container into the vacuum station with the glass facing you and the handle up.
Press the vacuum button to activate the vacuum process.
4. Once the procedure is complete, remove the ClearCoast™ tissue container and insert it into the ClearCoast™ MRI system.

Technical data

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

Literature

  1. Maloney, B. et al., Review of methods for intraoperative margin detection for breast conserving surgery, J Biomed Opt. 2018, 23(10): 1-19

  2. 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

  3. Walijee, J. et al., Predictors of re-excision among women undergoing breast-conserving surgery for cancer, Ann Surg Oncol. 2008; 15(5): 1297-303

  4. 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

  5. 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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