STRATELUS has completed the project A Non-Invasive Expert System for Diagnosis of Intraocular Tumours (NICDIT) supported by the EU Eurostars programme. The aim of the project is to develop a new expert system for diagnostics and analysis of intraocular tumours. The project is being implemented by a consortium of Stratelus, Kaunas University of Technology Ultrasound Institute, Kaunas University of Technology Biomedical Engineering Institute, Optomed (Finland), and Lund University Electric and IT Technologies Department (Sweden). The project was running from 2008 to 2011.

The overall aim of the project is to create and introduce to the market a new expert system for analysis and diagnosis of intraocular tumours. It will consist of a new non-invasive ultrasonic tissue characterisation device (which will be developed and prototypes produced in the course of this project) to the conventional ultrasound diagnostic system for acquisition of ultrasound RF signals, sophisticated software for ultrasonic data analysis, and the innovative digital ophthalmoscope for acquiring images of intraocular tumours. The ultrasonic tissue characterisation device – an option to the conventional ultrasonic diagnostic systems for advanced data acquisition, processing and analysis system with automatic decision feature (further referred to as "Device RF") will fulfil the market demand, because it will respond to the clinical needs for a reliable method of intraocular tumours diagnostics. It will be compatible with the majority of commercially available diagnostic systems and will fit the advanced requirements of the end-users at a competitive price.

The clinical reasoning behind the project is that differential diagnosis of human eye tumours is one of the most important problems in ophthalmology in dealing with cancer prevention and diagnostics. Malignant eye tumours make 0.2 per cent of all malignant tumours diagnosed, but it is a direct reason of death for each third patient. In ophthalmological practice and treatment, intraocular tumour differentiation is one of determinant factors for management and outcomes of a disease. Recently, the main method for differentiation of intraocular tumours globally has been the use of invasive methods (e.g. fine needle biopsy) and like all invasive methods, it has had it's limitations. Therefore, offering an early non-invasive diagnosis and characterization of tumour's tissue is crucial for proper treatment prognosis of the tumours and death prevention.

The most common current method for eye tumour diagnosis is ophthalmoscopy - optical subjective evaluation of the eye fundus.  Ophthalmoscopy is an obligatory method in ophthalmological examination. It is sufficient to diagnose an intraocular tumour but insufficient for differential diagnosis and evaluation of its structure.

Complex optical and ultrasound- based investigations are the leading noninvasive methods for intraocular tumours diagnosis, differentiation, tumour geometrical and structural parameters evaluation. There are several indicators used for ultrasonic diagnosis of intraocular tumours in vivo: geometry, size, shape and structure are frequently used in clinical practice.  Non-invasiveness, high resolution, and informativeness make ultrasound investigation one of the most effective and efficient diagnostic method in ophthalmology. A-scan (one-dimensional detected signal), B-scan (two-dimensional image), 3D and ultrasound biomicroscopy (UBM) technique are used for tumour characterization. However, ultrasound radiofrequency (RF) signal provides more information in comparison with the detected signal or images. Thus, the way to increase resolution of commercially available ultrasound imaging systems and characterization of biological tissues is acquisition and processing of ultrasound RF signals.  However, RF signals acquisition is not available in the equipment currently available on the market worldwide .  This makes a gap between the demand and availability and creates a market opportunity.

The ultrasonic diagnostic system that will be developed in the course of this project could be implemented into other clinical areas (such as oncology). The developed product will be offered for end-users (doctors) and beneficiaries (patients/the society) and is going to be a high value-adding system enabling faster and better-informed diagnostic decisions of potentially terminal diseases at a reasonable cost. As the result, quality of diagnostics and treatment will be improved essentially and probability the patient mortality related to malignant eye tumours will be reduced.

The project was implemented by a consortium that will include clinical, technological and market expertise and will consist of Stratelus, a telemedicine development and services company, Optomed, Biomedical Engineering Institute of the Kaunas University of Technology, Ultrasound Institute of the Kaunas University of Technology and Department of Electrical and Information Technology of Lund University.

Please contact Prof. A.Paunksnis at alvydas(a)stratelus.com for more information about the project and it's outcomes

The innovativeness of this project is extension and application of existing technologies to new areas.

The purpose of the project is to create a qualitative new, safe, non-invasive system, consisting of a specialized technical equipment - a Device RF – the option to the conventional ultrasound scanner for acquisition and collection of RF signals from intraocular tumours and a sophisticated software for data processing and parameterization. The created product will be compatible with most ultrasonic diagnostic equipment (scanners) on the market, and will give new information about tumour tissue paremeters and will satisfy specific end users' clinical/technological demands.
The fact that ultrasound RF signal carries more information for the clinical decision making, for intraocular tumours in particular, is not a new knowledge and technologies for processing the ultrasound RF signal have existed, but this technology hasn't been developed to the hi-end level and  applied in commercially available medical equipment offered to end-users.
The technical tasks within the project are:
1) To develop methodological principles for evaluation and differentiation of intraocular tumours.
2) To provide an extensive analysis of clinical ultrasonic RF signals by means of flexible virtual instruments and to create optimal algorithms for extraction of most informative parameters for tissue characterisation.  
3) To create a sophisticated software for data collection, integration and processing including user friendly interfaces for management of test procedures, data parameterization and decision support.
4) To provide high performance eye fundus imaging device for visual examination of intraocular tumours accessible for basic healthcare units.
5) To design a special hardware for acquisition, processing and storage of RF signals.
6) To develop adaptive model based signal and image processing software for calculation of diagnostic parameters in order to obtain specific quantitative indicators for diagnosis and differentiation of intraocular tumours.
As a result of this project, scientific knowledge and competency of every partner will be elevated, knowledge exchange process will be developed and possibilities for new market development will appear.
The created system using appropriate information and communication technologies would provide more convenient intercommunication among physicians, by performing consultations, information and knowledge exchange for fast differentiation of diagnosed tumour. Hereby the time between the right diagnosis of eye tumour and effective treatment would be minimized and the probability of patient’s death decreased.
Innovatition of the product offered, technological advancement, compatibility and ease of use will make it acceptable and marketable not only on the Lithuanian market but also internationally - for the Baltic, Scandinavian, EU, North American and other health care and diagnostics centers.

The overall project result was that an expert system comprised of a sophisticated and adaptive software based on digital models for ultrasonic signals processing and innovative hardware will be created and offered to the market for discovering and classification of intraocular tumours in a more effective and efficient way than other methods and systems (equipment) currently available on the clinical market.

Stratelus was the leading partner and project coordinator of the Eurostars NICDIT project.
Participants: Optomed OY (Finland), Biomedical Engineering Institute of Kaunas University of Technology (Lithuania), Ultrasound Institute of Kaunas University of Technology (Lithuania) and Department of Electrical and Information Technology of Lund University (Sweden).

Stratelus has completed a pilot screening project aimed at early diagnostics of diabetic retinopathy and ageing macula degeneration and use of e-health tools in remote locations in Lithuania.

Project partners:

ALCON PHARMACEUTICALS Lithuania Rep Office

SANTEN OY 

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