Clinical validation of Laser Optoacoustic Ultrasonic 3D Imaging System Assembly for breast cancer detection and characterization through endogenous biomarkers.

Project Information

LOUISA-3D

Grant agreement ID: 672213

DOI 10.3030/672213

Project closed

EC signature date 14 April 2015

Start date 1 May 2015

End date 31 October 2015

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost € 71 429,00

EU contribution € 50 000,00

Coordinated by

BIOS S.R.L.
Italy

Objective

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.

Fields of science (EuroSciVoc)

CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.

• natural sciences › physical sciences › nuclear physics
• medical and health sciences › clinical medicine › oncology › breast cancer
• engineering and technology › medical engineering › diagnostic imaging › magnetic resonance imaging
• natural sciences › physical sciences › optics › laser physics
• natural sciences › physical sciences › acoustics › ultrasound

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Programme(s)

• H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme
• H2020-EU.3.1.3. - Treating and managing disease

Topic(s)

• PHC-12-2014-1 - Clinical research for the validation of biomarkers and/or diagnostic medical devices

Call for proposal

H2020-SMEInst-2014-2015

See other projects for this call

Sub call

H2020-SMEINST-1-2014

Funding Scheme

SME-1 - SME instrument phase 1

Coordinator

BIOS S.R.L.

• Net EU contribution: € 50 000,00
• Address: VIA GUIDO ROSSA, 10/12 ; 20090 VIMODROME ; Italy
• SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes:
  Region
  Nord-Ovest › Lombardia › Milano
• Region: Nord-Ovest › Lombardia › Milano
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: € 71 429,00