Case study: Study Support Service - Developing a device for earlier diagnosis of diagnosis of pre-cancerous colon polyps
The NIHR supports medical technology, device and diagnostic companies in the innovation and translation of new medical technologies and diagnostics.
SpectraScience is a U.S. and Dutch-based medical technology company. Its focus is on cancer diagnosis and specifically the early detection of colorectal cancer (cancer in the lower bowel) using a light-based technology. By achieving more accurate and earlier diagnosis, SpectraScience’s vision is that more patients will be diagnosed at a stage where their disease can be effectively treated. The result will be improved outcomes for patients and a reduction in overall treatment costs.
The MORDIS study (Multicentre, Open, Prospective Study on Modified Resect and Discard Strategy of Small Colonic Lesions) utilises the latest technology from SpectraScience. The WavSTAT4 Optical Biopsy System is used during routine screening (colonoscopy), alongside the normal screen procedure, to predict whether polyps (small new tissue growths) in the colon are benign or cancerous/precancerous.
Benign polyps (also called ‘non-suspect polyps’) would generally not be removed but cancerous/pre-cancerous polyps (known as ‘suspect polyps’) must be removed. However, during screening it can be diffi cult to tell the difference between the two types, which leads to the removal and subsequent laboratory testing of many tissue samples. This extensive sampling is often impractical, time-consuming and costly.
Preliminary results of the study, which was undertaken at St James University Hospital using the Wavstat4 system, indicate that it is highly accurate (96%) in predicting when a polyp is non-suspect. This means that during screening for bowel cancer less polyps would need to be removed which would save both time and resource in terms of clinician time and laboratory testing.
The MORDIS study team accessed a range of NIHR support.
The study was first brought to the attention of the NIHR when the company accessed the NIHR Signposting Service. This service introduces companies to a full range of experts who can collaborate on clinical research and help develop a potential therapeutic or technology for use in a clinical setting. The range of experts includes: clinicians, laboratory scientists, health economists, statisticians, methodologists, biomedical engineers and world-leading experts and specialists in a range of therapeutic areas.
The NIHR team connected SpectreScience with Dr Venkat Subramanian who works within an NIHR Surgical MedTech Co-operative (previously known as an NIHR Healthcare Technology Cooperative) in England. Dr Subramanian collaborated with SpectreScience to help translate the light-based technology into the clinical setting and develop a feasible study protocol.
Study Support Service
The study opened in February 2015 at St James’ University Hospital, Leeds, in the UK. The NIHR Study Support Service assisted study set-up by helping the company to obtain the relevant research and development (R&D) permissions. The NIHR Study Support Service also supported study delivery by allocating Clinical Trial Assistant support (funded by the company) to Dr Subramanium for one day a week to assist with administrative tasks associated with the study. This included screening clinic patient lists to identify patients that might be suitable and that would benefi t from taking part in the MORDIS study.
This support contributed to the overall success of the study. The UK recruitment target was to recruit 100 patients. When MORDIS closed as planned in August 2016 a total of 122 patients had taken part which equates to 122% of the recruitment target.
“It was extremely helpful to have the services of [NIHR] connect us with Dr Subramanian. With their help we were able to conduct our clinical evaluation with investigators who are both influential and engaged with improving the state of cancer diagnostics to benefit NHS patients. Their knowledge and professionalism was critical to our success.” Michael Oliver, President and CEO of SpectraScience
Dr Venkat Subramanian, Chief Investigator of the study and Clinical Associate
Professor and Honorary Consultant Gastroenterologist at the University of Leeds,
commented on the potential clinical impact of this new technology:
“Further work will be needed to assess potential cost savings for the NHS and how well this technology enables clinicians and endoscopists in diverse settings to set appropriate follow up schedules for patients with colorectal polyps detected during colonoscopy. Further UK trials are also likely to be required to ensure the technology can be used effectively by the different kinds of endoscopy centres that exist in the UK.” Dr Venkat Subramanian