LOUISA-3DProject ID: 672213
H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being
Clinical validation of Laser Optoacoustic Ultrasonic 3D Imaging System Assembly for breast cancer detection and characterization through endogenous biomarkers.
Gesamtkosten:EUR 71 429
EU-Beitrag:EUR 50 000
Thema(en):PHC-12-2014-1 - Clinical research for the validation of biomarkers and/or diagnostic medical devices
Aufruf zur Vorschlagseinreichung:H2020-SMEINST-1-2014See other projects for this call
Finanzierungsprogramm:SME-1 - SME instrument phase 1
Breast cancer (BC) is the most common cancer and the first cause of cancer-related deaths in European women. Laser Optoacoustic Ultrasonic 3D Imaging System Assembly (LOUISA-3D) combines optoacoustic functional information from endogenous biomarkers (hemoglobin content and blood oxygen saturation) with high-resolution anatomical images of ultrasound tomography, without the need for ionizing radiation or exogenous contrast media. The objective of LOUISA-3D is to overcome the main limitations of current imaging methods, by validating and introducing to the EU market a novel multi-modality diagnostic device for BC, based on coregistered full view 3D optoacoustic and ultrasonic technology. LOUISA-3D will be a highly effective, safe and affordable imaging method for BC detection, characterization, and evaluation of the effect of neoadjuvant therapy (NAT).
Two clinical trials will validate LOUISA-3D. Trial 1 will measure detection rate, recall rate, sensitivity, and positive predictive value of LOUISA-3D as a screening test in a selected female population at increased risk for BC, as compared to standard digital mammography. Trial 2 will assess the LOUISA-3D endogenous biomarkers capability of measuring the NAT effect in the treatment of locally advanced BCs, as compared to contrast-enhanced magnetic resonance imaging. During this feasibility study, an international scientific committee will deliver both trial protocols, and a management board will release a work and financial plan for the trials and a business plan for the production and commercialization of LOUISA-3D, complete market analysis, cost analysis and financial plan.
The applying company, Bios, commercializes medical laser systems worldwide. Once validated and CE medical marked, LOUISA-3D will be manufactured and commercialized in EU, representing an important opportunity for Bios to enter the medical imaging market and enable its significant growth.
EU-Beitrag: EUR 50 000
VIA GUIDO ROSSA, 10/12