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

Projektinformationen

LOUISA-3D

ID Finanzhilfevereinbarung: 672213

DOI 10.3030/672213

Projekt abgeschlossen

EK-Unterschriftsdatum 14 April 2015

Startdatum 1 Mai 2015

Enddatum 31 Oktober 2015

Finanziert unter

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

Gesamtkosten € 71 429,00

EU-Beitrag € 50 000,00

Koordiniert durch

BIOS S.R.L.
Italy

Ziel

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.

Wissenschaftliches Gebiet

• 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

Programm/Programme

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

Thema/Themen

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

Aufforderung zur Vorschlagseinreichung

H2020-SMEInst-2014-2015

Andere Projekte für diesen Aufruf anzeigen

Unterauftrag

H2020-SMEINST-1-2014

Finanzierungsplan

SME-1 - SME instrument phase 1

Koordinator

BIOS S.R.L.

• Netto-EU-Beitrag: € 50 000,00
• Adresse: VIA GUIDO ROSSA, 10/12 ; 20090 VIMODROME ; Italien
• KMU Die Organisation definierte sich zum Zeitpunkt der Unterzeichnung der Finanzhilfevereinbarung selbst als KMU (Kleine und mittlere Unternehmen). Ja:
  Region
  Nord-Ovest › Lombardia › Milano
• Region: Nord-Ovest › Lombardia › Milano
• Aktivitätstyp: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Gesamtkosten: € 71 429,00