Frequently Asked Questions

Which EU Member States and which clinical sites are currently involved in EUCAIM?

The EUCAIM website provides information on the clinical sites involved in EUCAIM project, with an overview per country, differentiated by provider type (research infrastructure, clinical centre, etc.). This information will be updated as new stakeholders are incorporated.

Will the federated infrastructure include histological images?

The infrastructure will address mainly medical images from devices such as for example MRI, CT, ultrasound, single photon emission computed tomography (SPECT), positron emission tomography (PET), X-ray, and mammography. In addition, the infrastructure is to be linked to other repositories, including biobanks for histological images, for example via the BBMRI-ERIC or the infrastructure created by the BIGPICTURE project.

How will the quality of data be controlled and ensured? We know that annotations vary from one institution to another. Will you have mechanisms to foster data quality?

It is an important challenge to curate the data in order to be able to develop robust AI models. EUCAIM has tools to monitor the image quality, in particular tools that can be used to annotate images through machine learning models, and tools to evaluate the quality of newly acquired images through a quality index score. Data quality criteria and data quality tools will be further elaborated by the project and data curation tools will be further improved. It is also expected that the infrastructure will help finding new self-learning methods to cluster the images and provide such services to data providers.

What is the role of proprietary data in the infrastructure created by EUCAIM project?

There are occasions when data is used that may be protected under a license, being proprietary to an organization or a project. All proprietary data will be identified in the data availability statement. The statement will further describe restrictions on reuse and federated use of this data. In the long term, EUCAIM will favour the storage of non-proprietary data within the Atlas of anonymised Cancer Images.

How will EUCAIM manage the legal requirements of the General Data Protection Regulation (GDPR) when collecting the data? In practical terms will data leave the hospital? How will you ensure data privacy?

This is a key standpoint for any European project based on unleashing access to health data. To ensure full compliance with data privacy principles, EUCAIM will be built under the data privacy by design and by default approach.

There are currently two scenarios for the implementation of the infrastructure: in the first one, data in the fragmented research repositories is already anonymised (e.g., data coming from fragmented repositories such as previously EU-funded projects and other research repositories). In this scenario, privacy is no longer an issue. Instead, the challenge will be how to make these repositories interoperable to be able to populate the Atlas of Cancer Images. Anonymized data from established research (such as data coming from clinical trials) will be easier to include, as this data is already pseudonymized and only a final de-identification step is needed (full anonymization).

In the second scenario, related to data at hospitals and real-world clinical practice, we are pursuing a federated learning approach, whereby the data remains distributed, stored at the local sites, with all the protective privacy measures in place. The data will not leave the hospital premises, safeguarding its privacy. As part of the project implementation, we will investigate how to do this securely and evaluate the associated risks. To allow this, the infrastructure software will get access to the data warehouse at the hospitals, for which the hospitals will need to have a structured data warehouse following the requirements that will be defined by the EUCAIM project. With data warehouses following these standards and the data being safe and quality-controlled, the process of extraction of the data from the Electronic Health Records (EHRs) to the data warehouse will be harmonised and normalised in an easier way. For this, a checklist will be provided by the project to the different hospitals, and if the hospital has enough computing resources, it may be possible to deploy AI solutions directly on the data in the hospital. The data won’t have to leave the hospital. The discussion on the best data warehouse architectures has already started. The project will publish these guidelines and checklist within the first year to provide technical guidance to individual hospitals.

Will clinical trial data from industry sponsored studies be included in the infrastructure? Are these data contributions from clinical trials already secured?

One of the objectives of the EUCAIM project is to support well-designed research on data, observational clinical studies and AI development trained and validated on a large number of images. Within the infrastructure, cases will be recruited from both real-world environment and completed clinical trials. Furthermore, the central hub will provide collaboration and support for the planning of observational clinical trials, targeting clinicians, researchers and innovators. EUCAIM work on technical AI developments on images and observational studies on data as emulated clinical trials will foster social innovation frameworks to produce practical insights in the real-world oncology practice. To do this, the infrastructure has incorporated and clustered not only technical and clinical partners, but also European Research Infrastructure Consortia (ERICs) and European coalitions dealing with patients, medical associations, academia, industry, enterprises, healthcare systems, regulatory bodies, and policy makers.

Once there is a solution, a model or a decision support system coming from observational study on retrospective data, this solution has to be validated in daily clinical practice. The best way to do that is through the initiation of clinical trials. It is within the scope of the project to define how these clinical trials have to be constructed. It is expected that clinical studies will then be initiated by pharmaceutical companies. EUCAIM stakeholders like the European infrastructure for translational medicine (EATRIS) will help on the definition of the clinical trials.

Countries from Central/Eastern Europe seem to be less represented in the EUCAIM consortium. Will there be opportunities for countries not represented yet to join the consortium? When?

The EUCAIM project will organise an Open Call to support the extension of the infrastructure, inviting new data providers and researchers to join. The Open Call for the federation of new data hubs will be launched, aimed among others at establishing longer-term collaboration with new cancer image data providers, including setting up the required technical infrastructure. The onboarding of new data providers is intended to increase the geographic dimensions, data modalities or cancer targets, and facilitate the uptake of new trustworthy AI algorithms trained on the data of the repository. This Open Call is expected to be published in 2024, with new data providers being onboarded in 2025. In addition, there will be an engagement strategy for new stakeholders to join the infrastructure from the beginning of the project.

Are there any clinical questions of particular importance that medical researchers would like to see addressed in EUCAIM?

Oncology is the main clinical aspect that will be addressed. There is no focus on specific pre-defined tumours or clinical questions. The project will deal with practical unmet clinical questions coming from researchers, practitioners and innovators, such as easy recognition of small lesions, phenotyping of tumours, dealing with prognosis and treatment allocation, and in the near future, evaluation of staging. The platform will be open to all types of tumours, including for example breast, lung, colorectal or skin cancer. Even though the platform will not initially focus on addressing specific clinical questions, it is planned that by project end a set of clinical use-cases will be chosen for platform testing and validation. This will allow fine-tuning of the different platform implementations in terms of requirements and capabilities.

Will there be any emphasis on childhood cancers and involving adolescents and young adults with cancer in research?

We aim for EUCAIM to become a cancer-neutral federated repository and to push the infrastructure to be able to solve clinical questions relating to all cancer types, including childhood cancers. The created infrastructure will be open to all cancer types and it will initially cover at least 5 cancer types: breast, lung, colorectal, prostate cancer, liver and paediatric tumours. The project builds among others on the results of the PRIMAGE project which was one of the biggest research projects on childhood cancer (neuroblastoma and Diffuse Intrinsic Pontine Glioma (DIPG)). PRIMAGE is one of the EUCAIM stakeholders and sharing cases and results is currently being discussed. The project will establish links to initiatives and projects working on paediatric cancers, such as the EU4Child project to explore synergies and links.

How will the Testing and Experimentation Facility for Health (TEF-Health) and EUCAIM be connected on the infrastructure level?

TEF-Health and EUCAIM represent two complementary pillars of the European Cancer Imaging Initiative. The design of EUCAIM will be technically compatible with the TEF-Health project (in terms of interoperability, standards, and data models). The EUCAIM consortium plans to closely collaborate with the TEF-Health project in order to ensure that TEF-Health is one of the processing back ends supported in EUCAIM. EUCAIM infrastructure follows a federated and distributed processing model, in which the TEF-Health could be considered as a supported backend for the processing of data. EUCAIM has defined a communication channel with TEF-Health to align the developments in both infrastructures.

How does the European Cancer Imaging Initiative ensure that there is (or will be) an active participation of the patients either as a stakeholder or a partner? How will patient representatives/organisations be involved in the EUCAIM project?

In addition to the different dissemination actions, the EUCAIM Engagement team will organise regular engagement meetings: including not only hospitals but also consultations with representatives from the main stakeholder groups: patients, data providers, service providers and data users in academia, industry and policy makers. The training activities will include activities targeting patients’ organizations to inform them on the secondary use of their health data for research and innovation (GDPR Compliance). Patients and patients’ organisations such as Patvocates and WECAN, the Workgroup of the 23 pan European cancer patient advocacy networks, will also be involved in the development of the Ethical, Legal and Social Implications (ELSI) data framework, for example they will be invited to participate in interviews and surveys. Moreover, the Stakeholder Advisory Board (SAB) which will be set up to gather and exchange additional feedback from stakeholders on the progress of the project. It will comprise representatives pertaining to the different partners and stakeholder groups in the remit of the project, including organisations representing patients such as the European Cancer Organization. Finally, the patients’ organisations will be closely involved in the work on data altruism.

How will you address the risk of participating institutions becoming more reluctant to share and annotate data as the time goes by/when the EU funding for the EUCAIM project is over? Do you have a policy in place to counter this risk?

At the outset, the EUCAIM project builds upon existing projects and research outcomes. It will link existing repositories and add new ones who are willing to share either metadata (catalogue) or data (images and related annotations). The risk of not having data is lower than in a standard research project, as EUCAIM builds on the AI4HI network of research projects. Since the beginning, EUCAIM will also work with the hospitals, to check on warehouses quality and support the hospitals in structuring their work to allow them to do observational clinical studies. The project will provide a seamless onboarding process and technical and legal support, including annotation tools to data providers. We expect that new hospitals that are not part of the consortium will see value in participating to maintain and ensure their own competitiveness on the national and European level as regards the participation in research and innovation projects and the construction of evidence-based tools ready to be brought to the market.

Will you engage with standardisation organisations to improve and adapt existing standards with project knowledge?

Standardisation and normalisation will be essential to the project. EUCAIM builds on the creation of similar projects which have already put an elaborated list of standards in place, particularly pertaining to interoperability standards for the infrastructure and data harmonization and standardization amongst others. The consortium is formed by experts in this field, and the project has a dedicated work package ensuring these standards are put in place and monitored throughout the project lifespan. Information technology standards on interoperability (such as Open ID, RESTful services, secure transport protocols), de-facto standards on dataset cataloguing and data representation, and standard file formats (such as DICOM) will be considered in the implementation of the infrastructure. The Spanish Association for Normalization (UNE) is also a stakeholder of EUCAIM and will provide consultancy and support on all the standards and norms that apply to the project.

For the sustainability and impact of the new services and infrastructure, it will be of interest to develop training solutions tailored to the new services (targeting health care professionals as end users). How do you envision the engagement of academia (universities, polytechnical schools) in this step?

As part of the project implementation, EUCAIM will create an Engagement team responsible for making connections with all types of relevant stakeholders, including not only start-ups, but also technical universities and hospitals. They will not only be actively contacted by the team but also regularly informed about the project progress, so that opportunities for involvement and collaboration can be created as the project evolves.

Is the European Cancer Imaging Initiative limited to AI or do you accept also other imaging technologies as hardware, software and firmware for time-of-flight PET for early cancer detection and low dose usage of FDG?

EUCAIM is a data infrastructure enabling a wide span of technologies, therefore is not limited to AI and is fully open to any technological improvement, including image acquisition. The scope of the Atlas of Cancer Images will be enriched by adding new data from new devices and protocols, as EUCAIM will stand as the platform for research and innovation on medical imaging by using any device and methodology.

Is there a plan to develop a standard content of the data to be made available to researchers? In particular, is data on radiation exposure to be included e.g., to allow developments around meeting EU legal requirements (Euratom Directive) for radiation protection of patients?

Standards will be used all over the platform. Partners related to standardization are within the EUCAIM Infrastructure. Standardized and structured DICOM data on radiation exposure will be incorporated and available within the platform.

Will Cardio Oncology Imaging of the heart be included in the Cancer Imaging and AI initiative? Cardiotoxicity and Heart Failure is one of the potential side effects of chemotherapy treatment of cancers.

EUCAIM is a pan-cancer Infrastructure, not limited to any specific cancer types. As such, images from all patients having all types of treatments will be incorporated. It is expected that the Atlas of Medical Images will also allow for the grading and estimation of toxicity and late side events, including cardiotoxicity.

How can a start-up with a proven technology to early detect cancer be part of this Initiative?

The best approach would be to first contact the to identify synergies and potential areas of collaboration. EUCAIM aims to use knowledge already generated and integrate already viable solutions, so interested parties with a solution in place may contribute by sharing their previous experience and expertise. EUCAIM is favouring start-up engagement through both and participating in our Stakeholder Board. The datasets available in EUCAIM will be organized considering regulatory practices, to facilitate the certification of new medical devices, by allowing the start-ups to develop clinical studies generating results ready for CE mark submission under the new Medical Device Regulation (MDR).

 

 

 

 

Survey Invitation

Join Leading Experts In Shaping AI In Cancer

EUCAIM is looking for your feedback! We have recently published a Stakeholder Survey in order to reach out to potential end-users and stakeholders. We believe that your insights could significantly contribute to understanding the expectations of potential users and identifying the essential aspects that stakeholders find crucial for future engagement and collaboration with the platform.

Therefore, we would like to invite you to participate in the Stakeholder Survey about the Cancer Image Europe platform.

Completing the survey will take approximately 10 minutes. Your participation is crucial to the success of this project, and we deeply appreciate your expertise in shaping the future of cancer imaging and treatment.