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Work Package 1: Coordination and Management
The overall objective of the coordination and management work package is the smooth implementation of the project and consists in the achievement of the following specific objectives:
- coordinate and supervise the project research and innovation activities according to the work plan, also by monitoring and ensuring quality and timing of project deliverables
- carry out the overall administrative and financial management and reporting of the project
- manage contacts with the Commission and establish effective internal and external communication
- resolve possible conflicts
- manage the IPR related to the achieved results
Work Package 2: Data collection and harmonization, and retrospective study
The general objective of this work package is to build a harmonised retrospective database of patients affected by vertebral metastases collected in four different clinical centres. In particular, it consists in the achievement of the following specific objectives:
- provide secure data collection mechanisms for both the retrospective (Train-METASTRA) and prospective (Validate-METASTRA) studies
- harmonise and standardise data from different sources
- provide secure data hosting and secure data access
- develop the METASTRA Data Management Plan
- segmentation tools for metastatic features
- design and conduct the retrospective study (Train-METASTRA)
Work Package 3: Data-driven, physiology-based biomechanical computational models, and Decision Support System
The general objective of this work package is to develop modelling approaches for the diagnoses of the risk of fracture (RoF) in oncologic patients with spine metastases, and for simulating the biomechanical effects of surgical treatments. WP3 consists in the achievement of the following specific objectives:
- Develop data-driven models for the prediction of RoF in patients with spine metastases (METASTRA-AI)
- Develop of physiology-based biomechanical models for the prediction of RoF in patients with undetermined outcomes from data-driven models (METASTRA-VPH)
- Identify the criteria required to run METASTRA-VPH
- Develop physiology-based biomechanical models for simulating surgical treatments in patients with spine metastases (METASTRA-VPH-TREAT)
- Develop the app to implement the decision support system (METASTRA-DSS)
Work Package 4: Verification and validation of computational Models
The general objective of this work package is to build the credibility of the mechanistic modules and of the AI and VPH models (from work package 3) through a systematic verification & validation process. In particular, it consists in the achievement of the following specific objectives:
- Design the roadmap for the verification and validation to ensure that it will be suitable for future certification of the DSS
- Verify the AI-based computational models
- Validate the mechanistic modules and the RoF predictions from the entire METASTRA-VPH for spines with metastatic lesions
- Validate the physiology-based biomechanical models for simulating surgical treatments of spines metastases
Work Package 5: Prospective clinical study and validation of computational models in clinical settings
The general objective of this work package is testing the applicability, usability, and predictive capacity of the METASTRA tools in the clinical environment using the prospective data of a large number of patients suffering from vertebral metastases. In general, the current (literature and experience based) patient stratification process will be compared in detail to the METASTRA-supported (patient-specific biomechanics based) decision making pipeline. Beside the structural collection of data and user experiences (surgeons’ feedback), the predictive power of the METASTRA based patient stratification will be assessed by the analysis of the standard follow-up data.
- Design and conduct the retrospective study (Validate-METASTRA)
- Assessment of reliability of METASTRA tools in patient stratification
- Measurement of users’ experience to help integration to clinical practice
Work Package 6: Regulatory roadmap and guidelines
The general objective of this work package is to set up the steps to obtain the CE mark of METASTRA-DSS as Software as Medical Device (SaMD) and to elaborate guidelines to support clinicians in the decision process of stratifying the fracture risk in patients with vertebral metastases and in identifying the best treatment and, in particular, it consists in the achievement of the following specific objectives:
- Design of the regulatory roadmap for CE mark as SaMD
- Assurance of software quality throughout development
- Author guidelines to stratify patient fracture risk and personalise treatment
Work Package 7: Innovation management: communication, dissemination, exploitation
WP7 will ensure consistent communication and dissemination, assuring optimal visibility and a wide outreach to relevant stakeholders. Strategic planning and implementation of project exploitation through dedicated innovation management will safeguard that high-quality results are captured, assessed and used. A proper IP management strategy will lay the foundation for further exploitation and sustainability activities.
- Communication, creating visibility and broader outreach
- Disseminating results to targeted stakeholders and the scientific community
- Health economic assessment
- Fostering innovation capacity and exploitation of results – incl. IP management