ABOUT THE SOLUS PROJECT

The most important things you need to know about SOLUS. If you are looking for more information about the separate Work Packages, CLICK HERE. More information about the consortium and each partner can be found HERE.

PROJECT DESCRIPTION

FACTS AND FIGURES

Acronym:

SOLUS

Start date:

November 1st, 2016

Duratio:

48 months

End date:

October 31st, 2020

Project coordinator:

Prof. Paola Taroni, POLIMI

Consortium:

9 PARTNERS - major universities, industry, research institute, clinic - from 5 countries

Total funding:

€3,815,260.00

PROJECT CONTEXT

Breast cancer is the most common cancer in Europe for females, and the most common cancer overall, with more than 464,000 new cases diagnosed in 2012 (29% of female cases and 13% of the total). About 1 in 8 women in Europe will be diagnosed with this disease during their lifetime [1]. Early diagnosis of breast cancer is essential to ensure a high chance of survival of the affected women. Therefore, it is crucial to provide diagnostic tools with high sensitivity for early detection, and high specificity to avoid false positive results. The International Agency for Research on Cancer (IARC) has recently confirmed the clear effectiveness of mammographic screening in reducing breast-cancer mortality (23% reduction in women 50 to 69 years of age). At the same time, screening mammography and secondary prevention programs result in detection of a significant number of previously occult benign breast lesions with a high rate of false positive cases. The cumulative risk of a false-positive mammogram over a 10-year period of yearly screening is on average of about 50% to 60% [2], leading to needless additional imaging and invasive procedures, like fine-needle aspiration cytology, core biopsy or surgical excision, with negative impact on the patient’s quality of life and high burden for the healthcare systems. Such unnecessary invasive procedures should be avoided.

There is a clear unmet need for a non-invasive diagnostic tool to achieve a more specific breast diagnosis, and improve the quality of life of more than a million of European women every year.

OBJECTIVES

Our main objective is to develop an innovative, multi-modal tomographic system, combining diffuse optical tomography and ultrasound/shear wave elastography to support the in vivo diagnosis of breast cancer. The multi-modal system aims at the classification of breast lesions after a positive screening, with special focus on improving the discrimination of lesions that are borderline between benign and malignant (BI-RADS 3 vs. 4a) and presently undergo screening evaluation with high false positive rate.

More specifically, we aim to:

- Develop an innovative, ground-breaking, low-cost, small size photonic module (smart optode) to perform in-depth diffuse optical tomography

- Assist the development of novel photonic approaches and their combination in a novel multi-modal probe

- Develop an innovative multi-modal optical-US/elastography tomographic system for high-specificity multi-parametric breast imaging and diagnosis of breast cancer

- Assess the multi-modal system performance in terms of sensitivity, spatial resolution and quantitation in laboratory settings

- Validate the multi-modal system, demonstrating the feasibility and the advantages of the proposed multi-modal solution in real clinical settings

PROJECT OUTPUT AND DELIVERABLES

The key output of the project will be the SOLUS multi-modal clinical device. A secondary output of the project will be the smart optode as a stand-alone exploitable result. Additionally, SOLUS will publish several reports, research results and part of its research data.

IMPACT

SOLUS will offer an affordable and highly specific, point-of-care system. We will achieve a substantially improved in-depth diagnosis of breast lesions and more effective treatment of breast cancer. This improved and faster in-depth diagnosis avoids unnecessary biopsies.

The substantial improvement in the characterization of breast lesions also leads to higher specificity in non-invasive breast cancer diagnosis. Women receiving a negative report will be spared unnecessary additional examinations.

The new SOLUS system will allow more effective treatment and management. Novel and improved therapy response prediction and monitoring, enable personalised decision-making and therapy planning and optimisation for each patient. This also contributes to a significant decrease of total cost of breast cancer diagnosis.

Furthermore, SOLUS will contribute to a and reinforced industrial European leadership in the biophotonics related market for analysis and diagnostic imaging systems

1. Wabnitz, H., Taubert, D.R., Mazurenka, M., Steinkellner, O., Jelzow, A., MacDonald, R., Milej, D., Sawosz, P., Kacprzak, M., Liebert, A., Cooper, R., Hebden, J., Pifferi, et al. Performance assessment of time-domain optical brain imagers, part 1: Basic instrumental performance protocol. J Biom Opt 19:086010, 2014.

2. Independent UK Panel on Breast Cancer Screening. The benefits and harms of breast cancer screening: an independent review. Lancet 380:1778-86, 2012.