Juan A. Gómez Herrero 1, José Navarro García1, Carlos M. Atienza Vicente 1,2, José L. Peris Serra 1,2, María Jesús Solera Navarro 1, Juan Catret Mascarell3, José María Benlloch Babiera,4,5
1 Instituto de Biomecánica (IBV). Universitat Politècnica de València. Edificio 9C. Camino de Vera s/n (46022) Valencia. Spain
2 IBV Health Technology Group, Networking Biomedical Research Center (CIBER) in BIOENGINEERING, BIOMATERIALS AND NANOMEDICINE (CIBER-BBN)
4 Spanish National Research Council (CSIC)
5 Institute of Instrumentation for Molecular Imaging (I3M)
Alzheimer's disease affects 14 million people in the world. To facilitate the effectiveness of new treatments, early detection of the disease is vital. The Valencian company Oncovision, with the collaboration of the I3M and the Institute of Biomechanics (IBV), has developed a new diagnostic imaging equipment based on PET technology that will make it possible to detect the disease in very early stages and with a high degree of accuracy.
Alzheimer's is an irreversible and progressive neurodegenerative disease, and the most common cause of dementia among the elderly. Approximately 36 million people worldwide suffer from Alzheimer's disease or related dementia. At this moment in time, there is no effective treatment for Alzheimer's. Numerous studies have shown that certain metabolic patterns are associated with mental illnesses.
To detect Alzheimer's at an early stage, Oncovision, together with the IBV and the I3M, has developed an innovative diagnostic device based on medical imaging. Called CareMiBrain, the device uses PET imaging technology (Positron Emission Tomography) which makes it possible to observe the metabolism of different proteins (b-amyloid and Tau protein) in the brain and assess whether their behavior is normal or abnormal. If the latter, this would indicate the presence of Alzheimer's disease in its early stages of development.
CareMiBrain is primarily intended for use in hospitals in Europe, Japan and the United States, and more specifically in their neurology departments and units where neurodegenerative pathologies are diagnosed and treated. It is the only compact PET system dedicated to brain pathology at the present time.
This device is being developed within the framework of a project funded by the European Union’s Horizon 2020 Research and Innovation program, whose purpose is to help companies to bring innovative projects to market. Specifically, CareMiBrain has been endowed with 4.4 million euros, a lifetime of three years and the collaboration of the IBV, the I3M and some of the world's most advanced hospitals specializing in molecular imaging and with well-established clinical reputations in the field of brain imaging in Europe and the United States.
Thanks to this project, Oncovision has perfected this technology and has integrated it into a medical device that will be validated at the hospitals mentioned above. At the end of the project, four units will have been validated and will have the corresponding CE medical device marking that will position Oncovision as a world leader in this field and, by extension, the Community of Valencia. The company is confident that it will be able to start marketing the device in Europe by the end of 2018.
The main advantages of the CareMiBrain device with respect to other devices already on the market, are the following:
♦ It is the only device in the world that has a PET system dedicated exclusively to the brain, not to mention its very high resolution. (Less than 2 mm).
♦ Its high sensitivity, which means a lower dose of radiotracer is required, thereby resulting in a benefit for the health of the patient and a lower healthcare cost.
♦ Significant reduction in the cost of the device.
♦ Its smaller size compared to other PET systems (1.5 m2).
The core of the CareMiBrain device is a set of PET detectors (cameras) mounted in three stacked rings and placed inside a portable helmet. The unit is completed by an arm to which the helmet is attached, a seat for the patient and the main structure of the device (Figure 1, a photograph of the device). The technology behind the detection system has been developed by the I3M Institute of the Universitat Politècnica de València (UPV).
When designing the helmet, at the very outset of the project, the IBV conducted an anthropometric study on the heads of 417 Spaniards, in order to determine the optimum angle and the tilt range of the helmet. They also studied the most appropriate diameter for the PET detector rings and the optimal number of rings to ensure that the device can be used by as much of the population as possible (Figure 1).
Figure 1. Diagram of the PET ring system made for the anthropometric survey.
Ergonomic criteria were considered during the design of the mechanical system as a whole, such that the patient's head is positioned in the most comfortable and efficient way possible, avoiding awkward postures of the neck. In turn, the arm has been equipped with three independent movements to allow all the necessary mobility of the helmet, in an automated manner and with a controlled speed.
Finally, the main structure of the device serves as a support for the arm to which the helmet and seat are attached, and to house all the electronics associated with the PET detectors and the system that controls and moves the device as a whole (Figure 2).
Throughout the development process, validations were carried out with potential users, thereby making it possible to detect improvements that have been introduced into the design of the final units.
Figure 2. PET device in the premises of ONCOVISION.
The project will be completed with a clinical study, which will take place in the European and North American hospitals referred to above.
As a result of the European CareMiBrain project, healthcare centers throughout the world will shortly have an innovative device at their disposal, that will make possible the early detection of Alzheimer's disease, which affects a significant number of people at increasingly early ages and is one of the major health problems at the global level, for both patients and their families.
On the other hand, the Oncovision company has positioned itself as a world leader in dedicated PET devices, through its collaboration with such highly prestigious R&D&i centers in the Community of Valencia as the I3M and the IBV.
Finally, it is important to note that in addition to improving the Spanish return from these activities, European funding for research, development and innovation projects makes it possible to transform knowledge into innovative products that are manufactured in our community and that generate wealth and quality employment.
The European Commission.
This project has received funding from the European Union’s Horizon 2020 Research and Innovation program through Contract No. 711323.
Oncovision and the I3M, for having relied on the IBV to draft the proposed instrument for SMEs in both Phase 1 and Phase 2.
MIPESA, which has been responsible for the manufacture and assembly of the mechanical parts of the device, in such a complex system.