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

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.

Field of science

  • /social sciences/economics and business/business and management/commerce
  • /medical and health sciences/clinical medicine/radiology/medical imaging/magnetic resonance imaging
  • /natural sciences/physical sciences/acoustics/ultrasound
  • /social sciences/economics and business
  • /medical and health sciences/clinical medicine/oncology/cancer
  • /medical and health sciences/clinical medicine/radiology/medical imaging
  • /medical and health sciences/clinical medicine/oncology/cancer/breast cancer
  • /natural sciences/physical sciences/optics/laser physics

Call for proposal

H2020-SMEINST-1-2014
See other projects for this call

Funding Scheme

SME-1 - SME instrument phase 1

Coordinator

BIOS S.R.L.
Address
Via Guido Rossa, 10/12
20090 Vimodrome
Italy
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 50 000