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Case studies

Improving confidence in intra-operative cancer detection technologies

Pre-clinical evaluation of new intra-operative cancer detection equipment and techniques

Case study

The need

In the coming years, cancer will remain one of the primary global public health challenges. According to the current predictions, by 2020, almost 50% of the world's population will be diagnosed with cancer within their lifetime. For cancer patients, surgery remains the primary choice of treatment. Despite the technological advancements achieved in pre-operative imaging and diagnostics, surgical procedures still rely on the doctor's ability to detect cancer through touch and the naked eye. This means it is based on individual expertise and can lead to inefficient removal of cancerous cells. Either some may remain within the body after surgery and require further treatment or, conversely, healthy cells may be incorrectly removed, leading to post-operative complications. These issues incur costs both for the patient and for the healthcare system.

The implementation of new intra-operative cancer detection technologies requires the use of realistic test objects, known as phantoms, to assess the effect of such surgical tools on patients. Phantoms must reproduce the physical properties of tissues to test radiation attenuation and analyse the 3D-distributions of radiopharmaceutical activity, goals that existing, simple optical phantoms cannot achieve. In phantom manufacturing, a further challenge is the use of a standard digital model for production, allowing test measurements to be linked to published research and standards.

The solution

Through NPL's medical imaging accelerator for industry programme, funded through the Industrial Strategy Challenge Fund, NPL worked with Lightpoint Medical to test a miniaturised intra-operative cancer detection probe, which allows accurate removal of cancer cells in a single operation. Using NPL's radiation test facilities, Lightpoint performed feasibility studies of the technology and verification of the probe against standard models.

The laparoscopic probe was tested on a radiation phantom for proctectomy, and a prototype 3D-printed pelvis model built using a bone-like material developed at NPL. The model has fillable organ inserts for the testing of radiation absorption and scattering properties of the intra-operative device. The radiological phantom has been a joint design effort and involved the development of novel techniques which will form the basis of further collaboration and improvements in cancer surgery.

The impact

Working with NPL enabled Lightpoint Medical to perform the pre-clinical evaluation of their product more effectively. They gained confidence in the probe's performance in an experimental environment that reflected the real world, and this could not have been achieved in another way.

The probe is currently nearing the end of its product development phase, and funding has been secured from Innovate UK to initiate the first in-man study. This clinical trial will enable CE Mark and FDA approval in 2020 for sentinel lymph node biopsy; this short trial time was possible by using pre-approved drugs.

The laparoscopic device will be used for intra-operative detection of sentinel lymph nodes and lymph node metastasis during prostate cancer surgery. Currently, high-risk prostate cancer patients undergo a full removal of the pelvic lymph nodes, an invasive procedure that leaves patients with significant complications often resulting in additional treatment. A commercialised miniature probe will allow surgeons to detect cancer cells precisely during surgery and spare healthy tissue, potentially improving patient outcomes while reducing complications and healthcare costs. The device is a significant step to solving the problem of cancerous tissue detection in the surgical field, and will be the first in the world to be approved and commercialised.

Lightpoint Medical has been shortlisted for the Collaborate to Innovate awards, held by The Engineer magazine, to recognise the significance of the collaborative work conducted through this project.

About the customer

Lightpoint Medical was founded in 2012 with the goal of becoming the world technology leader in targeted cancer surgery. The company's technology has the potential to detect cancer in real time during surgery, enabling surgeons to remove the cancerous tissue while sparing healthy tissue. The technology is based on administering the patient a cancer-targeted imaging drug and then detecting the cancer live during surgery.

Since the founding of the company, Lightpoint has achieved clinical trial data in multiple cancer types, regulatory clearance, and is well on its way to transforming the practice of cancer surgery.

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