A new clinical technology to improve detection of cancerous polyps during colonoscopy is being investigated, with support from the Colorectal Therapies HTC and funding from Innovate UK’s Small Business Research Initiative.
The technology involves the use of an imaging agent, EMI-137, given to patients intravenously prior to their colonoscopy and which, under fluorescent light, allows clinicians to spot lesions more easily. Standard colonoscopy uses white light and up to 26 per cent of small or flat lesions can be missed. Currently, all potentially cancerous lesions are removed during endoscopy and sent for biopsy. EMI-137 should enable clinicians to accurately differentiate between cancerous and non-cancerous lesions, improve lesion removal and potentially in the future reduce or replace the need for biopsies, and ensuring more appropriate follow up.
The HTC is working with Edinburgh Molecular Imaging Ltd (EM Imaging), who have licensed the technology, to help them put the necessary steps in place to move towards regulatory approval Phase III clinical trials. This will include a health economics analysis by the University of Leeds and an assessment of the technology’s diagnostic accuracy, to be conducted by the NIHR Diagnostic Evidence Cooperative, based at Leeds Teaching Hospitals Trust. A Phase IIb clinical study of 50-100 patients involving Leeds, Edinburgh, Leiden and Groningen will further validate the technology and its impact on overall workflow. It is hoped the Leeds team will look in key at risk CRC groups such as inflammatory bowel disease patients
HTC Programme Manager, Dr Neville Young, will coordinate the Leeds-based elements of the project.
“The accuracy of the technology, its ability to potentially eliminate the need for pathology and its impact on healthcare costs are all interlinked,” said Dr Young. “It’s our job in the HTC to help coordinate those different aspects, so that EM Imaging are able to use the real time data from the forthcoming trial to get a true picture of the technology’s potential.”