MAMMOCARE

Breast biopsy system guided by Positron Emission Mammography allowing real-time 3D visualization of tumour lesion and needle insertion guidance for higher sampling accuracy and efficiency

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 Obiettivo del progetto (Objective)

'Breast cancer is the most frequent cancer among women and one of the leading causes of cancer-related mortality and early diagnosis is essential to reduce the risk of mortality. First diagnostic tool is clinical imaging (mainly Mammography and Ultrasound) but suspicious findings usually require a biopsy to confirm the diagnosis; 2% of women who undergo a screening mammogram will require some type of breast biopsy (1,3 million women each year in Europe).

Breast biopsy is an image-guided procedure that can use different imaging technologies. Apart from US-guided biopsy, which is a manual procedure with limited indications, all current solutions are based on discrete scans of static images taken at different steps during the procedure. This guidance method makes current biopsy techniques to be long procedures with limited accuracy.

MAMMOCARE project will develop a PEM (Positron Emission Mammography)-guided breast biopsy system allowing real-time 3D visualization of the lesion and real-time guidance with continuous monitoring of both, lesion position and needle motion. The system will also allow for preoperative planning of the optimal needle path. Exclusive PEM technology used, having the highest sensitivity and spatial resolution in the market, will allow the detection of small lesions difficult to find with conventional morphological imaging technologies, contributing to earlier diagnosis.

Real-time monitoring and control of biopsy procedure, together with the high precision mechanics of the biopsy positioning module will assure an accurate sampling of the target lesion as well as shortening the procedure with regard to current techniques.

Thus, the consortium will offer an integral diagnosis system based on PEM Imaging, including a biopsy module compatible with this kind of imaging technology.

The consortium integrates 3 SMEs with experience in PEM imaging technology, Mechatronics applied to medical devices and Software Development. Two of the partners will become providers of their developed technologies of the third partner which will integrate the whole MAMMOCARE parts and commercialise the final product. SMEs will increase their portfolio as well as their revenues, while opening new doors to other markets thanks to the knowledge acquired.

R&D activities will be carried out by CSIC, IBV and HERI, increasing their expertise and knowledge, reinforcing new research lines and future projects. Clinical feasibility of the system will be assessed through a clinical validation study at the facilities of NKI, collaborating end-user, therefore demonstrating the MAMMOCARE contribution to defeat women breast cancer.'

Introduzione (Teaser)

Breast cancer constitutes the most frequent form of cancer in women. Efforts to improve diagnostic precision rely on novel imaging methods.

Descrizione progetto (Article)

Breast cancer diagnosis is performed using clinical imaging modalities such as mammography and ultrasound. However, nearly 2 % of women with abnormal findings require a biopsy to confirm the results. Breast biopsy is an image-guided procedure that is time-consuming and of limited accuracy. Ideally a biopsy procedure should be comfortable for the patient with minimal risk of injury.

To improve the overall performance of the technique, scientists on the EU-funded MAMMOCARE (Breast biopsy system guided by Positron Emission Mammography allowing real-time 3D visualization of tumour lesion and needle insertion guidance for higher sampling accuracy and efficiency) project propose to develop a system that relies on positron emission mammography (PEM). This novel technology offers high sensitivity and spatial resolution to detect small lesions that are difficult to find with conventional imaging technologies. To achieve its goals, the consortium integrates the expertise of three small- and medium-enterprises in PEM imaging technology.

The MAMMOCARE system is designed to allow real-time three-dimensional visualisation of the lesion and guidance of the needle. The latter is facilitated by high precision mechanics of the biopsy positioning module to reduce inadequate sampling and positioning errors associated with other methods.

During the first part of the project, the teams worked closely to ensure that all operational, security and ergonomic aspects of the system design are integrated with the mechanical parts. Considerable efforts have also gone into the design of the software components for system control and interoperability.

Following research and development activities, partners plan to perform a clinical validation study. In that respect, they have completed the clinical protocol and defined the patient inclusion and exclusion criteria.

The deliverable of the study is a PEM system prototype for breast cancer imaging and biopsy that is ready to enter the market. PEM-guided imaging is anticipated to reduce the duration of the biopsy procedure and benefit over 30 000 women through prompt and more accurate diagnosis.