HEALTHCARE Phase three is based on compelling results
from the company’s phase two study, which saw residual and otherwise invisible tumour tissue detected. Te study, which was published in Te Lancet Gastroenterology and Hepatology, demonstrated that the use of SGM-101 during surgery can lead to a modification of surgery in 35 per cent of patients with recurrent or peritoneal metastases of CRC, either by allowing more aggressive resection of tumour tissue or by preserving healthy tissue. Quest agreed to provide 12 Spectrum platforms to those medical centres participating in the trial.
Clinical trials Phase three was designed after discussions with the US Food and Drug Administration (FDA), alongside other regulators. Te trial aims to enrol 300 CRC patients in 10 clinical centres across Europe and the US to assess the safety and clinical benefit of using fluorescence-guided surgery with SGM-101 as an intraoperative imaging agent to better identify cancer lesions during the surgical procedure. Patients are injected with 10mg of SGM-101 four days prior to the scheduled CRC surgical procedure. Te first US patient has recently been
recruited into this important phase, with four US facilities currently taking part, including: Cleveland Clinic Florida, Massachusetts General Hospital, Moores Cancer Center and the Abramson Cancer
‘Identifying the malignant tissue is sometimes difficult. You can’t always see it with the naked eye’
Center of the University of Pennsylvania. Meester said: ‘We are excited to move
forward to phase three in order to prove the utility of image-guided surgery, specifically in CRC surgery, which is the third most common type of cancer, affecting people all over the world.’ SurgiMab is optimistic about the results of this next phase, as expressed by CEO Dr Françoise Cailler: ‘If this trial successfully demonstrates that the use of SGM-101 improves tumour resection, we believe that this could provide a new approach for close to 150,000 patients diagnosed with CRC every year in the United States, most of whom undergo surgery.’ Preliminary data is expected next year.
Rise to the challenge One of the challenges for manufacturers of vision technology for healthcare is just
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angles must be set precisely here. Such positioning normally is achieved using well-made mechanical systems, i.e. using classic processes like turning, milling, or grinding, depending on the material and geometry. If there are higher requirements on positioning accuracy, one must either design certain elements to be finely adjusted using micrometre screws or use techniques like ball chuck centring or adhesive bonding adjustment in the lens.’
The Spectrum system includes a multispectral camera which pictures cancer cells and tissue differences not visible to the human eye
how precise the manufacturing process needs to be. Dr Stefan Beyer, director of product development, medical applications business unit at Berliner Glas, explained: ‘No other industry requires such precise manufacturing processes. In order to make the best possible use of light as a tool with all its fascinating properties, it requires thinking in the dimensions of light and lower. Furthermore, optical applications are not limited to the range of visible light, with wavelengths between 400nm and 700nm; they include the entire spectrum from extreme ultraviolet to far infrared.’ Products for which these highly precise
processes are necessary, said Beyer, include optical lens systems or multi-chip modules like those installed in high-quality medical cameras. ‘Te multi-chip prism assembly, for example,’ he said, ‘which is used in endoscopic cameras, among other things, is tasked with splitting light into its spectral components, capturing a high-quality image via individual sensors, and merging them again electronically. With resolutions increasing – from HD to 4k to 8k – pixel sizes decreasing accordingly, and data volumes growing, the requirements to adjust sensors to the pixel are increasing to the same degree.’ In fact, stated Beyer, in the area of optics
and precision engineering, everything on the spectrum smaller than 10µm is considered a demanding positioning task. ‘In optical systems with moderate requirements,’ he said, ‘lenses are aligned to one another at typical distances of 20µm to 50µm (air gap) and at height differences of around 10µm to 20µm with respect to a common optical axis. Naturally, the
A good resolution Berliner Glas has developed a tool that can achieve a positioning accuracy of less than 1µm in order to position multiple elements simultaneously with high precision. Te actuators used here are hexapods that allow adjustment on small assembly spaces in all six degrees of freedom. ‘When aligning in the micrometre range,’ said Beyer, ‘one must differentiate between the precision before and after the adhesive cures. Before hardening, precision of better than 250nm can be achieved, meaning quarter of a micrometre or half the wavelength of green light. Corresponding measurement equipment and optimised software algorithms are required to even be able to detect such values. If one uses, for example, image sensors to detect positioning, one can precisely determine the position of an edge at better than one tenth of a pixel using appropriate software. For 2µm pixels, the resolution is better than 200nm.’ In medical applications, there is a
noticeable trend towards miniaturisation, so that smaller, more portable or table- top devices can be situated in theatres for easy access for surgeons. Tis trend often requires functional elements to be positioned in the single-digit micrometre range, said Beyer. ‘One could argue that insufficient precision could be offset through the use of software today,’ he said. ‘Tis is true, but only if there is no unknown information hidden in the system. Interpolating data points can only allow us to guess, not measure. An incorrect resolution, caused by poor alignment, always leads to more noise in the end, and thus to a higher uncertainty in the information.’ With the Berliner Glas adjustment
platform the above and other electro-optical components can be precisely aligned for numerous visual procedures, including the kind of fluorescence imaging methods provided by companies such as Quest. Beyer concluded: ‘By merging highly
precise production processes for individual components and aligning them to one another with high precision, the result is a system that is capable of bringing out the maximum performance of a device.’ O
DECEMBER 2019/JANUARY 2020 IMAGING AND MACHINE VISION EUROPE 25
Quest Imaging
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