Development of novel components and subunits
Work Package 1

This Work Package (WP) will develop new single-photon detectors, compact laser systems and fast timing circuits for building an integrated smart optode. The latter will be incorporated in ultrasound probes for combing optical tomography and ultrasound elastography for the classification of breast lesions. WP1 will lead to:

• Time-gated single-photon detector with wide active area dedicated to diffuse optics.
• Compact laser system based on an integrated driver for fast-pulsed laser diodes.
• Fast timing circuit for acquiring the distribution of photons arrival times.
• Smart optode, integrating the laser system, the fast-gated detector and the timing electronics.

Modelling, computation and data processing
Work Package 2

The main objective of WP2 is to provide the measurement strategies, algorithms, and software for optical characterization of breast lesions using ultrasound (US) priors. More specifically, WP2 will:

• Define the paradigms representing the clinical problem (breast bearing a suspect lesion).
• Identify the best measurement strategies to characterize optically the breast lesion against the criteria defined in WP4
• Provide segmentation algorithms for extracting US priors information to be used for optical tomography
• Identify the most effective reconstruction algorithms for lesion characterisation against criteria defined in WP4
• Provide the complete set of software tools to be used for phantom and clinical data analysis
• Complete the whole data analysis of the clinical validation exercise

Development of a multi-modal prototype for breast imaging
Work Package 3

The objective of this work package is to conceive and build up a new multi-modal system presenting the combined functions of US imaging, Shear Wave Elastography (SWE) map and optical imaging. This system will be implemented on an US/SWE Aixplorer from SSI. In order to carry out this integration a new handheld imaging probe combining US transducer and the innovative optical subunits developed in WP1 will have to be designed and developed. This new probe will be linked to a global optical/US acquisition mock-up for which synchronisation and control software will be developed. A processing software integrating the dedicated algorithms for optical acquisitions and co-registration optical/us information developed in WP2 will be designed and integrated.

The specific aims are to:

• Design and build up a new handheld multimodal optical/US-SWE imaging probe
• Integrate a multi-modal acquisition electronic mockup for US and optical acquisition
• Integrate algorithms for optical and US-SWE data processing and co-registration

Testing and validation on phantoms
Work Package 4

The main objective of Work Package 4 is to validate each new photonic component, the single optode and then the whole SOLUS prototype on tissue-mimicking optical/ultrasound phantoms by following suitable protocols for performance assessment of diffuse optical systems. More specifically, WP4 will lead to:

• Definition of new specific protocols for multi-modal diffuse optical tomography/ultrasound (DOT-US) systems
• Design, fabrication and supplying of DOT-US joint phantoms
• Validation of performances of newly developed optode components
• Assessment of single optode performances
• Performance assessment of the multi-modal DOT-US acquisition and of the final SOLUS prototype

Validation in clinical settings
Work Package 5

The objective of this WP is to develop clinical protocols, obtain ethical approvals and test the multi-modal SOLUS system in real-settings, in terms of its usability and integration into the clinical and radiologist work-flow for breast nodule characterization, and to carry out a pilot study to evaluate it on real benign and malignant breast nodules.

Specifically, this work package will:

• develop a clinical protocol to evaluate the potential of the SOLUS system for the characterization of breast nodules, benign vs malignant
• obtain the ethical approvals for a study on subjects diagnosed with breast nodules.
• test procedures, evaluate and provide feedback on the usability of SOLUS and its potential integration into the clinical work-flow.
• carry out a pilot feasibility study on subjects with benign and malignant breast nodules.
• analyze data and assess the future potential of SOLUS from a clinical end-user viewpoint.

Communication and dissemination
Work Package 6

The main objective of WP6 is to develop, coordinate and pursue the overall communication and dissemination strategy and activities for SOLUS. Input to this horizontal WP will be required from all partners. WP6 is tasked with:

• Handling the project’s internal communication strategy to ensure effective collaboration within the consortium. A dedicated, secure online platform will be provided by EIBIR, which allows partners to review and complete tasks assigned to them, and collaborate on documents together with a version-control system.
• Dealing with the external communication and dissemination of the project to raise awareness of the project and its innovative developments, demonstrate the benefits for all end-users, and receive feedback from the scientific and clinical communities.
• Promoting wider acceptance of the proposed solutions by disseminating the results of the project by communication targeting the professional end-user communities, the appropriate public authorities, other relevant stakeholders as well as the general public.

Exploitation
Work Package 7

The main objective of work package 7 is to prepare the commercial exploitation of the results of the SOLUS project. The results include the developed system, the subcomponents of the system or the knowledge that was generated during the course of the project. More specifically, the WP7 will document the key attributes of the potential products and services derived from the project to support the decision of creating, developing and commercialising them.

The objectives of WP7 are to:

• Develop and update an Exploitation Plan, to be used as a long term guidance for the exploitation of the outputs of the projects, and to drive the exploitation phase during the lifespan of the project.
• Evaluate the different dimensions of the SOLUS system for breast imaging to decide the design of an integrated product, its production and sales (intellectual property, clinical performance, safety issues, product cost, industrialization strategy, etc.) to commercially exploit the results of SOLUS.
• Evaluate the capability to commercially exploit the optode component for the OEM market in different markets and in different form factors.
• Evaluate the opportunity of extending the use of the SOLUS device or its subcomponents to other fields of imaging (other clinical segments, coupling to other modalities or without other modality, association to optical contrast agents).
• Manage the intellectual property rights, from the survey of anterior art to the exploitation of the generated intellectual property.

Project management
Work Package 8

Work Package 8 is tasked with the overall project coordination and management of SOLUS. WP8 will:

• Establish the SOLUS governance structure and coordinate meetings and activities of the governing bodies, monitor overall project progress
• Handle the day-to-day management and logistics of SOLUS and manage financial, administrative and contractual aspects of the projects
• Quality assurance and risk management
• Coordinate all project communication
• Ensure proper data management