The surgeon’s sense of touch
Breast cancer accounts for 28% of all cancers diagnosed in women, with about 15,000 women and 120 men diagnosed in Australia each year. About 60-80% of women with early-stage cancer will undergo breast-conserving surgery.
As breast tumour tissue is typically stiffer than surrounding tissue, surgeons rely on their sense of touch or their eyesight to identify cancer tissue during surgery. In 20-30% of cases, some cancer tissue is undetected and left behind and patients will require repeat surgery.
For patients, this means further pain, anxiety and expense. There is also added financial burden on the health care system.
20-30% of patients will require repeat surgery
A very BRITELab
Associate Professor Brendan Kennedy, of the Department of Electrical, Electronic and Computer Engineering, The University of Western Australia (UWA) leads a team of biomedical engineers at UWA’s Bio imaging Research and Innovation for Translational Engineering Lab (BRITELab) based at the Harry Perkins Institute of Medical Research (HPIMR).
The work began in 2008 when A/Prof Kennedy worked in the Optical+Biomedical Engineering Laboratory (OBEL) at UWA and has accelerated since the creation of BRITElab in 2016. Since the beginning of the project, the biomedical engineering team have worked closely with leading breast cancer surgeon and UWA researcher Professor Christobel Saunders. Also in 2016, OncoRes Medical was created to commercialise the technology developed in UWA. The BRITElab team continue to work closely with OncoRes Medical as the technology is developed towards routine hospital use.
The team are developing a high resolution, hand-held probe used by surgeons during breast-conserving surgery, to identify all the tumour tissue and reduce the need for repeat surgery.
The BRITELab team had three main research requirements when developing their technology:
- measure stiffness
- see stiffness on a microscopic scale
- relate their images on stiffness to clinical outcomes to test its accuracy
The ultimate goal of this research is to use our engineering skills to be able to help surgeons.
Translating the surgeon’s sense of touch
The team are passionate about their technology and the impact that it will have. If the potential of the technology is realised, following breast conserving surgery, the patient and surgeon will have more confidence that there’s no more cancer left behind.
The probe translates the surgeon’s sense of touch into small, high-resolution images, enabling them to more accurately and effectively identify and remove tumours during breast-conserving surgery. Whilst a hand-held probe is the most practical solution for the surgeon, it has come with an array of engineering challenges that the team have had to solve, particularly the motion artefact created by movement of the surgeon and the patient.
One of the most critical things is that as engineers, we work to develop a tool that surgeons really want to use. There’s no point in us having a technology that’s a 100% effective but is too clunky for surgeons to use in a surgical setting.
Measuring stiffness from a new angle
Many diseases, including breast cancer are linked to stiffness in the cells. Whilst measuring stiffness at a microscopic level is complex, it has the potential to dramatically improve the accuracy of surgery.
Around 2019, the team began refining the technology, quantitative micro-elastography (QME), to implement it in a hand-held format. QME combines an existing optical imaging technique, optical coherence tomography (OCT), with mechanical deformation. The team developed a number of variations of the technique before settling on the QME technique in 2015.
- OCT uses light waves to generate 3-D, high-resolution images of tissue.
- QME generates 3-D maps of tissue elasticity to measure stiffness of the tissue.
Their 2020 clinical study, which compared the two techniques on breast tissue from 90 subjects, proved that QME was significantly more accurate (95%) in detecting the presence of cancer cells, within the surgical tumour margins, than OCT alone.
If we can achieve that level of accuracy in the hand-held probe, we can substantially reduce the amount of re incisions required.
Using OCT to measure stiffness in breast tissue
A steady hand
When a surgeon is pressing on tissue during surgery, any hand motion or movement of the patient can disturb the measurement of tissue.
In 2008, the team began collaborating with Professor Saunders to explore the idea of a device for use during surgery and by 2011 they were able to prove that technology worked, in a lab environment. By 2012, preliminary and clinical studies had started on excised human breast tissue at Royal Perth Hospital. Their first research papers were published in 2014 and 2015.
In January 2019, the team proposed that by using a hand-held contact probe, in place of cumbersome support apparatus or mechanical arms, they could overcome the issue of operator correction during a scan.
By April, the team presented the first finger-mounted probe that implemented their QME technique. In August, a hand-held probe was used to perform QME scans on human breast tissue specimen. To date, the team have worked on tissues from about 250 patients.
In addition, Professor Saunders and her colleagues have used the probe on 12 patients during surgery. Clinical studies continue at Fiona Stanley Hospital, with a view to including Royal Perth Hospital and Fremantle Hospital.
So far, the clinical studies on quantitative micro-elastography have been very promising, which gives us hope that this technology can help to address the high re-excision rate during breast-conserving surgery
The hand-held probe used during surgery
Seeing cancer in 3-D
Most existing techniques are unable to study the cell properties on a microscopic scale.
The team’s intraoperative imaging technology translates a surgeon’s sense of touch into a microscale 3-D image to improve accuracy in cancer removal and reduce complication rates. The device also does not expose the patient or the surgeon to any additional radiation.
The team’s first clinical study in 2015 to investigate visualising cancer in human tissue used their OCME technique, and lay the foundation for their future intraoperative studies.
They developed algorithms to overcome the challenge of image distortion between the probe and tissue during use. As well as an algorithm, that enabled 3-D imaging of a cell using QME and successfully revealed stiffness of tumour tissue. For surgeons, this development means they can potentially survey the breast cavity by moving the device along the inside of the breast tissue. During each pause, a three-dimensional image is taken, in less than a second.
The next stage is to commercialise a hand-held QME probe with the ultimate goal of enabling QME to be performed intraoperatively by surgeons globally.
Now we can achieve images with just as good quality with a hand-held device as we can achieve on the bench top version of the technology.
The OCME technology will help surgeons visualise cancer in human tissue
The business at hand
OncoRes Medical was founded in 2016, based on the work undertaken at UWA. WA Health and UWA were co-founders of the company.
The team worked closely with Dr Samantha South in UWA’s Research Development and Innovation team to commercialise the technology as a product, leading to the creation of OncoRes Medical as a UWA start-up.
Collaborating directly with surgeons’ means that the team at BRITELab are uniquely positioned to combine their expertise to develop a technology that is practical for surgeons to use in a surgical scenario.
We’re taking each of the steps that are necessary to get this across the line and into the hands of surgeons worldwide.
For the technology to become a product, it will need regulatory approval in the United States of America, the biggest global market. The team are also in discussion with academic surgeons in the United States of America, and the United States Food and Drugs Administration (FDA).
Engaging with patients is also important to the team. Patients have been encouraged that this technology may be available in the next 4-5 years, and comforted that it will be available to help future patients.
The next step is to commercialise the probe.
Funding success
To develop this technology takes enormous resources, and the team are grateful for the financial support they receive on this project from funders:
- Australian Research Council
- WA Department of Health, Medical Research Commercialisation Fund
- Cancer Council WA
- National Breast Cancer Foundation
- NHMRC
- OncoRes Medical
When you’re developing a technology like this that requires technical development and clinical studies, funding and resources to make it happen are really important. We like to thank all those who have been very generous in awarding us funding.
Global recognition
The multi-disciplinary team are recognised globally for their technology
OncoRes Medical has been proactive in capital raising and promoting the team, which is developing a name worldwide for their cutting-edge technology. Their reputation has grown, following a number of awards in recent years.
- 2019 – Tech23 Greatest Potential Award
- 2019 – Emerging Company of the Year, Ausbiotech and Johnson & Johnson Innovation Industry Excellence Awards
- 2018 – joint winner at the international start up competition London Pitch; pre cursor to Pitch at Palace
- 2018 – Audience Vote Winner, Pitch@Palace Australia 2.0.
- 2019 – Value Award Winner, MedTech Innovator Accelerator Conference, USA
The close collaborations between our engineers and physicists here in the lab, and the surgeons, pathologists and clinical researchers during clinical trials is fundamental to the success of the project so far, and to its continuing success in the future.
This Western Australian innovation is on its way to improving the safety and reliability of breast conserving surgeries, worldwide. This technology will greatly improve health outcomes for patients, and will provide significant cost savings for our health system and the economy.
Hey KIDDO, improve your move!