First Breast Biopsy System Offering Real-Time Monitoring and Guidance
Breast cancer is by far the most frequent cancer among women, with an estimated 1,38 million new cancer cases diagnosed in 2008 (23% of all cancers) and one of the leading causes of cancer-related mortality. Just within the European Union, every 2.5 minutes a woman is diagnosed with breast cancer, and every 7.5 minutes a woman dies from the disease (3% of cancer deaths in European women is produced by breast cancer). Besides, it is estimated that about one in 12 women will develop the disease before the age of 75 years.
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.
The objective of the EU-funded project entitled MAMMOCARE is to develop a breast biopsy system guided by 3D real-time PEM (Positron Emission Mammography) imaging and offering real-time guidance and correction of the needle trajectory for higher accuracy and efficiency in tumour sampling. It would be the first breast biopsy system in the market offering real-time monitoring and guidance. The system will automatically calculate the best needle position to perform the biopsy and it will be placed and inserted accordingly for the physician to extract the selected sample.
Exclusive PEM image technology used in the system, having the highest spatial resolution and sensitivity in the market, will allow for detection of smaller lesions (1,5-2 mm) that could not be found out with other more conventional image technologies like RX, US or MRI, or even other PEM scans in the market, and is also able to display heterogeneous uptake in malignant breast tumours, contributing to earlier and more precise diagnoses.
The biopsy module will offer a higher accuracy than current image-guided biopsy systems in order to enable targeted sampling of small tumours, thus making feasible to diagnose breast cancer at very early stages, improving patient prognosis and survival chances. In addition, the biopsy module will be more accessible in order to reach more difficult areas not possible with other techniques, while reducing risk. In addition, procedure duration will be shorter than the current PEM-guided biopsy, offering overall a cost-efficient alternative for breast cancer diagnosis.
MAMMOCARE is a European project funded by the Research Executive Agency, through the Research for the benefit of SMEs programme, under the 7th Framework Programme of the European Union. The Kick-Off Meeting of the MAMMOCARE project took place at ONCOVISION's facilities in the Príncipe Felipe Research Centre in Valencia (Spain) in October 2013. The consortium integrates 3 SMEs with experience in PEM imaging technology, Mechatronics applied to medical devices and Software Development: ONCOVISION (Coordinator) (Spain), Statice (France) and Virtual Angle (Netherlands). Research & Development activities will be mainly carried out by the Institute of Instrumentation in Molecular Imaging (I3M) of the Spanish National Research Council (CSIC) (Spain), the Instituto de Biomecánica de Valencia (IBV – Biomechanics Institute of Valencia) (Spain) and the UK Health & Environment Research Institute (UK). Clinical feasibility of the system will be assessed through a clinical validation study at the facilities of Stichting Het Nederlands Kanker Instituut – Antoni Van Leeuwenhoek Ziekenhuis (Netherlands), collaborating end-user.