Personalised response monitoring in oncology: co-creating clinical trials in advanced breast cancer

Informazioni relative al progetto

PREMIO COLLAB

ID dell’accordo di sovvenzione: 101136812

DOI

10.3030/101136812

Data della firma CE 8 Dicembre 2023

Data di avvio 1 Gennaio 2024

Data di completamento 31 Dicembre 2029

Finanziato da

• Health

Costo totale

€ 7 543 676,25

Contributo UE

€ 7 537 801,25

Coordinato da

REGION SYDDANMARK
Denmark

Periodic Reporting for period 1 - PREMIO COLLAB (Personalised response monitoring in oncology: co-creating clinical trials in advanced breast cancer)

Periodo di rendicontazione: 2024-01-01 al 2025-06-30

Sintesi del contesto e degli obiettivi generali del progetto

PREMIO COLLAB’s vision is to prolong overall survival and improve the quality of life for patients with metastatic breast cancer (MBC) by providing refined guidance for managing response monitoring. PREMIO COLLAB strives to facilitate improved patient care and streamlined clinical workflows addressing the needs of patients, healthcare professionals, and society. Response evaluation methods for patients with MBC have not been modernised for decades, although molecular imaging with FDG-PET/CT has emerged as a highly accurate method for staging MBC, and staging and monitoring MBC has a profound influence on treatment options and the chances of survival. Furthermore, the patient perspective has rarely been considered, although continuous response evaluation in a monitoring setting has interacted with the life of MBC patients for years. Here, Social Sciences and Humanities (SSH) play an important role by ensuring that patient perspectives are integrated into study design and implementation. Still, no specific recommendations are provided internationally for response evaluation in MBC or in the overall management of monitoring. PREMIO COLLAB offers complementary competencies in an interdisciplinary collaborative effort to lift this complex task. In a pragmatic multicenter randomised clinical trial (RCT), we will apply the intervention of FDG-PET/CT-based monitoring and compare it with conventional CT as state-of-the-art. The objectives are to analyse the impact of the intervention on overall survival and quality of life in patients with MBC and include cost-effectiveness analyses directly informing HTA agencies and health policymakers. Building on knowledge from the RCT, we will use participatory research designs to develop improved and modernised patient pathways and digital workflows. AI-based solutions in imaging and liquid biopsies constitute perspectives with a broader horizon. The work will be done in multiple European centers and living labs with patient representatives, clinicians, and relevant stakeholders aiming to provide knowledge for updated recommendations with a view to subsequent clinical implementation.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

The PREMIO COLLAB project aims to deliver robust scientific evidence and innovative tools to improve monitoring of metastatic breast cancer (MBC). Activities are structured around clinical research, devel-opment of standardised response criteria, and future-oriented technological solutions.

The project will provide Level I evidence on the benefits of FDG-PET/CT compared to conventional CT for treatment response monitoring through a pragmatic randomised clinical trial. This study will assess patient-relevant outcomes, including overall survival and quality of life. Preparatory work has been done and includes establishing harmonised imaging protocols and ensuring feasibility of recruitment and data collection across participating sites.

Within WP6, updated response evaluation criteria tailored for FDG-PET/CT in MBC patients have been developed to reflect current clinical consensus and improve reproducibility. First version of Digital PERCIST – a dedicated software tool designed to support standardised application of the respons evaluation criteria in clinical workflows. The first version of both the response criteria and the digital tool will be further refined based on clinical feedback and ongoing research.

Looking ahead, the project will explore AI-based methods to automate image analysis and reporting, aiming to reduce the workload for imaging specialists, enhance diagnostic precision, and enable earlier detection of progression. Additional research will assess opportunities for integrating genomic data and liquid biopsies as complementary approaches to imaging, supporting more personalised monitoring strategies.

PREMIO COLLAB engages patients and families through living labs to co-design diagnostic pathways that reflect their needs and values. This approach will improve communication, support shared decision-making, and ensure that technological innovations enhance the overall patient experience.

Finally, PREMIO COLLAB will also generate cost-effectiveness analyses across European healthcare systems and provide guidance for policymakers on the organisational and economic implications of adopt-ing FDG-PET/CT for monitoring. These activities will ensure that implementation strategies are clinically effective, affordable, and sustainable.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

PREMIO COLLAB aims to overcome current limitations in monitoring metastatic breast cancer (MBC) by advancing both clinical evidence and technological solutions. Current practice relies on CT and RECIST criteria, which are often insensitive, especially in patients with bone metastases, leaving many without reliable response evaluation. PREMIO COLLAB introduces FDG-PET/CT with adapted PERCIST-MBC criteria, offering a more accurate and reproducible approach. Through a pragmatic randomised clinical trial, the project will deliver the first Level I evidence on the patient-relevant benefits of FDG-PET/CT, a major step beyond the current Level III evidence. This will shape clinical guidelines and inform health policy and reimbursement strategies, supported by cost-effectiveness analyses and organisational guidance tailored to national contexts. To support clinical uptake, PREMIO COLLAB develops digital tools that integrate FDG-PET/CT into routine workflows as seamlessly as CT is used today, creating a harmonised diagnostic framework. Future innovations include AI-driven interpretation and reporting, as well as the integration of liquid biopsies as potential gatekeepers for imaging. Together, these advances will improve accuracy, reduce workload, accelerate progression detection, and lower patient burden by limiting invasive procedures and radiation exposure.

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