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A Retrospective Analysis of Magnetic Resonance Imaging Data for Breast Cancer Screening in the Open Consortium for Decentralized Medical Artificial Intelligence

A Retrospective Analysis of Magnetic Resonance Imaging Data for Breast Cancer Screening in the Open Consortium for Decentralized Medical Artificial Intelligence

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05698056
Acronym
ODELIA
Enrollment
25000
Registered
2023-01-26
Start date
2023-01-01
Completion date
2027-12-31
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

artificial intelligence, biomarker, image analysis, MRI, radiology

Brief summary

ODELIA is a project that aims to improve breast cancer detection in magnetic resonance imaging by utilizing artificial intelligence and swarm learning (MRI). The project will create an open-source swarm learning software framework that will be used to train AI models for breast cancer detection. These models' performance will be compared to that of conventional AI models, and the results will be used to assess the effectiveness of swarm learning in improving the accuracy and robustness of AI models. The project will use retrospective, anonymized breast MRI datasets with manual ground truth labels for cancer presence. The study is not associated with any patient treatment or intervention. The project's goal is to provide evidence of the clinical benefits of swarm learning in the context of breast cancer screening, such as accelerated development, improved performance, and robust generalizability.

Detailed description

Artificial Intelligence (AI) is set to revolutionize healthcare as its diagnostic performance approaches that of clinical experts. In particular, in cancer screening, AI could help patients to make better-informed decisions and reduce medical error. However, this requires large datasets whose collection faces severe practical, ethical and legal obstacles. These obstacles could potentially be overcome with swarm learning (SL) where partners jointly train AI models without sharing any data. Yet, access to SL technology is currently limited because no studies have implemented SL in a true multinational setup, no freely usable implementation of SL is available, researchers & healthcare providers have no experience with setting up SL networks and policymakers are currently unaware of the broader implications of SL. ODELIA will aim to solve these issues: ODELIA will build an open-source software framework for SL, providing an assembly line for the streamlined development of AI solutions in a preclinical setting. To serve as a blueprint for future SL-based AI systems, ODELIA partners collaborate as a consortium to develop AI models for the detection of breast cancer in magnetic resonance imaging (MRI). The size of ODELIA's distributed database will be substantial and ODELIA's AI models could reach expert-level performance for breast cancer screening. Thereby, ODELIA will could not just deliver a useful medical application, but provide evidence to summarize the clinical benefit of SL in terms of accelerated development, increased performance and robust generalizability. To achieve this, ODELIA partners will collect retrospective, anonymized breast MRI datasets with manual ground truth labels for the presence of cancer, and will train AI models conventionelly and via SL. The performance of these technical approaches will be compared. The aim of the study is to test the methodology of Swarm Learning and the performance of AI algorithms developed within ODELIA on retrospective data. There will be no effect on treatment of patients as all evaluations will be done retrospectively. No patient treatment or any intervention is associated with the study.

Interventions

OTHERNo intervention.

No intervention.

Sponsors

European Institute for Biomedical Imaging Research (EIBIR), Austria
CollaboratorUNKNOWN
University Hospital, Aachen
CollaboratorOTHER
Vall d'Hebron Institute of Oncology
CollaboratorOTHER
Mitera Hospital
CollaboratorOTHER
Radboud University Medical Center
CollaboratorOTHER
UMC Utrecht
CollaboratorOTHER
Ribera Salud Hospitals, Spain
CollaboratorUNKNOWN
Fraunhofer Institute for Digital Medicine (MEVIS), Germany
CollaboratorUNKNOWN
University Hospital, Zürich
CollaboratorOTHER
Cambridge University Hospitals NHS Foundation Trust
CollaboratorOTHER
Technische Universität Dresden
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years

Inclusion criteria

* Female * age at the MRI examination from 18-90 years

Exclusion criteria

* insufficient image quality as judged by a blinded radiologist before start of the analysis * non-identifiably ground truth (i.e., diagnosis has not yet been established)

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performance for breast cancer detection (Sensitivity and specificity)5 yearsDiagnostic performance for breast cancer detection (Sensitivity and specificity) compared to the gold stnandard method of expert-based assessment of breast MRI, may be summarized in a receiver operating characteristic curve for multiple threshold values, comparing multiple technical approaches, including swarm-learning based AI models and local AI models.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026