The MICCAI conference 2009

Earlier this week, IXICO was exhibiting at the MICCAI conference in London. This is an international conference to do with the analysis of medical images – with lots of really mathematical stuff presented by computer scientists and engineers. MICCAI stands for Medical Image Computing and Computer Assisted Interventions, so as well as analysis of images, it also has presentations on robotics. The people presenting at the MICCAI meeting are trying to invent new ways of using images to diagnose disease, plan treatment, monitor treatment progress or even control robotic surgery. If you get your work accepted at MICCAI you are doing very well, as less than 10% of work submitted is accepted for a talk.

MICCAI this year was in London, and two of IXICO’s founders – Dave Hawkes and Daniel Rueckert – were involved in organizing it. One of IXICO’s software developers – Sergiy Milko– was also presenting his work.

The people coming to MICCAI all use medical images in their research, and so all have to deal with the problem of moving around these images, collecting them from scanners, ensuring patient privacy rules are obeyed, and sharing the images with colleagues. All too often, the medical images used in this sort of research are not very well looked after – and get lost or mis-placed. If you don’t know what sort of patient the images are collected from, then they become useless for almost all types of research.

That is one reason we decided that MICCAI would be a good place to show everyone Trial Wire - http://www.mytrialwire.com/ – our free tool to share, de-identify and organize your DICOM medical images, and also show people Trial Tracker – our latest product that provides a web-based image management system for comprehensive management of all imaging data from acquisition to analysis. You can get more information on Trial Tracker here www.ixico.com/newproducts/trialtracker

And I nearly forgot – a real highlight of MICCAI was the conference dinner. It was held in the Science Museum. London’s science museum contains fascinating material, from old steam engines to Apollo lander to CT scanners. On the computing side, it contains really ancient computer gizmos - Baggage’s mechanical computer from 150 years go, or the computer memory developed 50 years ago for the Manchester computer). You couldn’t do much image analysis on those systems: modern scanners can generate 1Gbyte of data per patient!

So it was among all these fascinating exhibits that the MICCAI banquet was held – with stilt walkers, jugglers, and a disco. Quite an event!
To find out more about MICCAI go to http://www.miccai.org/

A blog about the blogger

I first started to look for an intern to help out as part of the IXICO marketing team. To be perfectly honest, we were not hoping for too much: just someone who would benefit from the experience of working at a fast-paced company like IXICO. When I was introduced to Anthony Chao (the creator of the IXICO blog) through the Shell Step placement program I quickly realised that we were in for a bit of an experience ourselves.

Over the course of the eight weeks Anthony spent with us, he successfully managed to plan and execute the technology social media marketing strategy and increased traffic to our web site by more than 30%. In addition to a host of other successful projects, Anthony also started the IXICO blog as a way to develop IXICO's image in the industry as a thought leader and to generally increase IXICO’s presence on the web.

Due largely to its informative yet informal tone, the IXICO blog has been well received internally and externally. Going forward, our aim is to rotate the authorship of the blog to allow real company participation on a variety of topics, based on the different areas of expertise within our group. The blog will be a platform from which IXICO employees can voice their opinions on or insights into relevant areas of discussion. I am extremely excited about the possibilities and we are indebted to Anthony for his efforts in getting this off the ground.

The Shell Step scheme is a UK-based organisation that links together small- to medium-sized businesses and undergraduates. The recruitment process was easy, and the people at Shell Step were available throughout the internship to monitor progress.

In recognition for his achievements, Anthony won the Shell Step Regional Award for most enterprising student. He now will be representing his region and competing for the award for most enterprising student of South UK. The award ceremony will be held on the 22nd September in London. Good luck, Anthony!

Would we recommend having an intern? Absolutely! Not only is it great to see fresh new talent but it is good to give something back. We will definitely be considering the shell Step program next year. To find out more about the Shell Step program visit www.shellstep.org.uk

Kranti Parekh

Marketing Manager - IXICO. Ltd

HIPAA - The Hippocratic Oath for Techies

As technology proliferated into healthcare, especially in the radiological practice, privacy protection once again entered the limelight as new issues concerning electronic data have been raised. In the medical imaging industry alone, which is a small subset of the healthcare sector, IXICO can testify that vast numbers of medical images exist in electronic format for compact storage, easy maintenance and rapid retrieval.

However, the convenience of data access across networks extending far beyond clinical sites or hospitals means that the patient’s personal information is potentially at risk of becoming publicly available. For example, every level of image transfer presents a potential security threat: (i) the images could be accessed by unauthorized parties at the clinical site (confidentiality) (ii) during the image transfer, images could be intercepted and modified (integrity) (iii) the intended receiver of the images might not receive them (authentication).

To meet the demands of rapidly developing technology, the US instituted in 2003 the Health Insurance Portability and Accountability Act (HIPAA) in order to set and enforce the standards for protecting the privacy and security of healthcare data. Indeed, privacy protection in the healthcare sector has always been an important issue. One part of the Hippocratic Oath, penned more than two millennia ago, stated that ‘Whatever I see or hear, professionally or privately, which ought not to be divulged, I will keep secret and tell no one’. HIPAA can be seen as the equivalent of the Hippocratic Oath for anyone dealing with electronic medical data. Non-compliance with HIPAA regulations can have severe consequences, including heavy fines and potential prison time.

Patient privacy is clearly an area of increasing focus for both the healthcare and technology industries. The difficulty for medical practitioners and clinical trial sponsors alike is that compliance with the regulations is difficult to maintain; the regulations are often not clear in their application to new and emerging technologies and individuals are often faced with rather laborious routes to compliance. The goal is to simplify the process as much as possible through automation. Many medical technology companies, including IXICO, are developing tools to help comply with HIPAA regulations through computer-based automation. Promising technologies include data encryption, virtual private networks, data embedding, and audit trails. These tools will undoubtedly improve personal data security and may potentially provide the basis for updating the laws governing the practice of medicine in the modern medical arena.

DICOM – The Industry’s Equivalent of a .pdf File

The word DICOM has a certain buzz about it in the medical imaging community. A substantial part of IXICO’s business revolves around DICOM data analysis. However, despite the large amount of information available in DICOM format, we can testify from experience that it still remains hazy to many. Below is a short description that explains how DICOM came about and its relevance to the imaging community.

DICOM stands for Digital Imaging and Communications in Medicine. It was developed in the 1980s and eventually adopted by the medical imaging community to allow for ease of communication and data transfer. DICOM can be thought of as the medical imaging field’s equivalent of a .pdf file or the lingua franca for imaging systems.

The development of a universal industry standard was imperative as digital imaging began to be widely used. Although the 1980s saw the proliferation of magnetic resonance imaging and computed tomography, both of which allowed for an unparallel level of image detail, the emphasis is now on easy connectivity and seamless communication between different imaging devices to boost efficiency and workflow.

The imaging devices were initially designed as isolated equipment with their unique printing and archiving methods. Equipment vendors were thus free to use their own propriety formats for storing imaging data. An image from one vendor could not be viewed using another’s viewer. Adding to this, it came to the point that the vendors would alter formats such that images from older devices could not be read by newer ones. Slight changes in image formats made it a nightmare for display workstations as they were forced to accommodate each new format.

DICOM was born out of the need to develop an imaging standard that would simplify data transfer and archiving between the many vendors. The DICOM format is now a universal imaging standard that is compatible with different brands, modalities, and models of imaging devices. A DICOM committee of radiologists, imaging equipment manufacturers, and engineers are tasked with periodically producing technical guidelines regarding transfer between devices, archives, printers and display workstations. Major imaging equipment manufacturers are also encouraged to produce DICOM conformance statements for their equipment.

DICOM is now the industry standard for medical images. It has made things easier for devices to communicate, raised awareness for connectivity amongst consumers, immensely enhanced collaboration between manufacturers to improve their products, and had a dramatic impact on clinical workflows.

To go electronic or not to go electronic; that is the question.

With 1.6 billion internet users, even more widespread computer users, and the fact that electronic data capture (EDC) tools have now been available for over two decades, it came to me as a surprise to find out that the majority of clinical trials are still conducted using the primitive method of paper data collection and then computerizing them – a long and drawn-out process that is prone to error.

The sceptic within the industry would point out that EDC, despite being around for two decades, has failed to greatly improve the efficiency and accuracy of clinical data capture. Needless to say, this is due to the continued reliance on paper over complete computerization, caused in part by the misconception that electronic data is difficult to validate. If EDC is to take off, the entire process would need to be streamlined and integrated rather than continue an inherently inefficient element in electronic form.

Luckily for the medical imaging industry, there is no paper-based process to replace. From experience, it is safe to say that the use of radiographic films has significantly reduced over the last 10 years. They are instead being replaced by electronic images in the industry-standard DICOM format. However, one would have thought that with the advent of the internet, these electronic data would be transferred and shared electronically. Fuelled partly by the belief that internet transfer is insecure and in part by the lack of internet connection at some clinical sites, medical images traditionally have been burned onto CDs and then couriered off. This has in turn delayed quality checks and turnaround times for further image analysis.

P&G Pharmaceutical estimated that every extra day a drug remains in clinical studies costs the sponsor at least $600,000 in lost sales. For a blockbuster drug, the daily revenue lost could reach $8 million. It is therefore in the interest of clinical trial sponsors to support better electronic processes at the various phases of clinical development to achieve greater overall efficiency. In relation to medical imaging, a web-based image management system would potentially reduce transfer costs, accelerate turnaround times and provide access to data in real time. The electronic nature of medical images means less work is needed to change sponsor attitudes towards a more web-based process, backed by strong documentation of work being conducted under FDA guidelines.

Drifting in the Cloud

‘Cloud computing’ is a buzzword that caught my attention this week. It seems everything that was once firmly grounded – books, music, high street shops and even medical records – are drifting into the ‘cloud’. In a nutshell, this buzz concept means that users do not need to install or maintain any software themselves – all they’ll need is a computer and browser. They will harness the internet as a vast computing resource and connect to them and use them as needed.

Without realizing it, you may be a cloud user already. Facebook, Twitter, Email, YouTube, iTunes all allow electronic information to be stored and processed on computers in the ‘cloud’ and then delivered to you where and when you need it. In the healthcare industry, the web-based personal health records (PHR) is set to revolutionise communication between patients and physicians as both will be able to pull up medical records from the web.

Will pharma companies that run the clinical trials, which only tentatively shifted from ancient paper records to electronic data capture (EDC) and clinical trial management (CTM), embrace the Cloud? We are not sure.

Pharma giant Ely Lilly and Co uses Amazon’s Elastic Compute Cloud (EC2) for its R&D research. They have been ‘able to launch a 64 bit machine cluster computer working on bioinformatics sequence information, complete the work, and shut it down in 20 minutes’ and it only cost ‘$6.40’ (Dave Powers – Ely Lilly Associate Information consultant).

As pharmas seek to reduce time and cost of drug development, the demand for fully integrated, end-to-end clinical solutions will increase. Clinical cloud computing would not only enable a wide range of clinical applications to be tapped from anywhere but also allow for greater access to real-time information and enhanced collaboration between CROs and sponsors.

In relation to medical imaging, it is regrettable that many clinical sites still rely on CDs or specialised equipment to transfer DICOM images. Trial Wire was launched by IXICO as part of its effort to foster the adoption of a simple, web-based image transfer tool. Evidently, a complete cloud based image management is not available, even though its benefits are clear: reduce operational time, real-time access to trial images anywhere in the world, data sharing, enhanced collaboration, and accelerated error correction.

However, all this may just be wishful thinking. Let’s hope that pharmaceutical companies are prepared to drift into the clouds.

The Rise of Image Registration

In a typical clinical trial that makes use of imaging, a subject is often scanned multiple times over a period of weeks or months. In-order to get a precise assessment of how well the drug being tested works, you need to detect subtle changes in the patient which might have been caused by the drug. While radiologists are very skilled at detecting abnormalities in images, they are not so good at measuring change precisely. This is especially true if the changes are small, as, for example, in Alzheimer's disease where the brain shrinks by a tiny fraction each year.

The first step in comparing two images is to bring them into spatial alignment, a process referred to as registration. One of the original ways of aligning the images is to simply introduce an external marker attached to the subject such that it is easily detectable in the images. Since the early 1990s, however, computer algorithms that can register the images without using markers have been developed and these are now widely used.

The founders of IXICO, Derek Hill, Jo Hajnal, David Hawkes and Daniel Rueckert, pioneered several image registration techniques in the 1990s, and demonstrated the value of image registration in diagnosis, planning treatment and monitoring disease progression.

Here’s a few words from IXICO’s CEO, Derek Hill:

“Image registration is now such an important sub-field in medical imaging that there are now conferences dedicated to it. Two important branches of image registration are simple alignment of the images to correct for position differences (often called "rigid body") and image registration that tries to exactly map one image onto another by warping (often called "non-rigid"). In rigid-body registration, if you subtract the images after the registration, you can see areas where there has been change that may be due to disease progression or drug treatment. After non-rigid registration, however, the two images look identical and it is important to analyse the valuable information in the warps to get an indication of what has changed.

Image registration is not an end in itself but a means of making more effective use of medical images, especially where precise measurements are needed. Image registration algorithms are now commonly used in many clinical trial areas as a key step in the analysis, such as measuring brain shrinkage (atrophy) and the amount of blood flowing to cancer tumours.

However, image registration can also play a role in the trials well before making measurements, by ensuring the image data is of high quality. IXICO uses image registration algorithms to check that a subject was scanned correctly (in the right place in the scanner, and imaging the correct parts of the body), to ensure that the images with the same subject label are really of the same subject (accidental mislabelling of images is, regrettably, a common feature of clinical trials), and to detect whether scanners have gone out of calibration over time. In these situations, using registration methods on the data as soon as possible after it has been collected can enable potential bad data to be detected and dealt with before it is too late.”