Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - IBEX QDR (IBEX QDR: A Ground-breaking Technological Upgrade based on Quantitative Digital Radiography to Exploit the Full Diagnostic Potential of Standard Digital X-Ray)

Teaser

Bone Fractures are a very common health problem. Between 2,000 and 3,000 fracture patients are examined using X-rays at this hospital every year. Fractures usually happen when too much force is applied to the bone, usually during a fall or an accident. Fractures can result in...

Summary

Bone Fractures are a very common health problem. Between 2,000 and 3,000 fracture patients are examined using X-rays at this hospital every year. Fractures usually happen when too much force is applied to the bone, usually during a fall or an accident. Fractures can result in a partially or completely broken bone and sometimes broken in several places. Accurate diagnosis of fractures is very important in deciding their treatment.
The likelihood of suffering a fracture can be increased by bone conditions such as osteoporosis, a condition where your bones become fragile and brittle and break easily. Around 3 million people in the UK suffer from osteoporosis. Osteoporotic hip fractures occur in 1 in 3 women and 1 in 5 men over the age of 50 and are the most common cause of injury-related deaths in the UK. Fragility fractures are estimated to cost the NHS £2.3 billion in health and social care provision in the UK alone.
Once diagnosed, there are effective ways to treat Osteoporosis and prevent fractures. However, the X-ray scans performed at fracture clinics are currently unable to diagnose a patient’s bone health, and only a small proportion of patients diagnosed with fractures are referred for measurement of bone health at specialist DEXA clinics. DEXA clinics are heavily utilised and it routinely takes over 3 months from an ‘at risk’ patient (usually patients over 50 presenting with a low-impact fracture) first presenting at a fracture clinic to an accurate diagnosis of their bone-health.
Digital radiography systems are far more prevalent in hospitals than DEXA systems and are utilised for a variety of diagnostic procedures that require the internal body structures to be imaged, however they don\'t currently offer any form of quantitative information and suffer from the effects of scattered X-rays which degrade image quality.
The IBEX technology has the potential to make these systems more efficient and safer by removing the need for an anti-scatter grid to be used, resulting in the potential to collect images at a lower X-ray dose, and also enabling additional diagnostic information to be collected at the same time as a fracture is assessed.
The main aim of this project is to complete development of the IBEX technology and demonstrate its efficacy in a clinical study to support commercial exploitation and adoption by healthcare providers.

Work performed

The project has progressed well but some changes have been made to the product to reflect evolving customer demands. The initial project was to develop the technology based on the patented IBEX multi-absorption plate (MAP) technology but through continuous engagement with potential customers and some interesting development activity it was decided to refocus development on a software only solution that could achieve the objectives of the project in a more straightforward solution.
As such, the main areas of focus for this first period have been on the software development and on preparation of documentation for the clinical study.
Software development activities have brought significant improvements to the outputs of the technology and have also opened up additional development opportunities that could be exploited outside of this project. Key results have shown that the scatter correction algorithms are performing very well in comparison to anti-scatter grids and bone mineral density results on phantoms are showing good accuracy in comparison to DEXA.
There has been a significant amount of effort in implementing and improving quality procedures required to meet ISO 13485 accreditation and to collate information required for the clinical trial submission and the final clinical investigation plan is almost complete.
The other main area of effort has been in commercial engagement with potential customers. We have attended two major radiology conferences as technical exhibitors and the technology has been very well received by everyone we have spoken to. Discussions with contacts made are ongoing and efforts are being made to address questions and comments from these potential customers.

Final results

The results so far have shown that even in an incomplete state, the Trueview® technology compares favourably with, and in many cases outperforms, traditional anti-scatter grids and other software-based scatter correction methods. This is due to the real physics-based nature of the Trueview® algorithms as opposed to image processing-based methods employed by other companies. In addition to this, the quantitative information obtained using the Trueview® technology cannot currently be collected by any other digital radiography-based system, indicating true innovation.
The second period of the project will focus on finalising the Trueview® software and conducting the clinical study. It is expected that the clinical study will demonstrate that the image quality of the IBEX technology is equivalent to, and in most case better than, standard digital radiography. We also expect eh study to show that the technology has the potential to add DEXA equivalent bone mineral density measurement capabilities to standard digital radiography systems

Website & more info

More info: http://ibexinnovations.co.uk.