Method for tumor perfusion assessment in clinical trials...

A - Human Necessities – 61 – B

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A61B 5/05 (2006.01)

Patent

CA 2575358

In a clinical trial using dceMRI, the assessment of tumor perfusion has problems of noise and reproducibility. To address those problems, an end-to- end method develops and enforces a standard imaging protocol, ensures site compliance both by pre-qualification and throughout the trial, ensures that the scanners function properly both at the outset and throughout the trial, develops an analysis process with automation and quality control to prevent human error, and provides analysis software to perform the assessment and to provide an electronic audit trail.

S'agissant d'essais cliniques sous IRM améliorée par contraste dynamique, l'évaluation de perfusion tumorale pose des problèmes de bruit et de reproductibilité. Afin d'y remédier, on décrit un procédé de bout en bout qui permet d'établir et d'appliquer un protocole d'imagerie normalisé, d'assurer la conformité de site en phase de préqualification et tout au long des essais, de garantir que les dispositifs d'exploration fonctionnent correctement dès le départ et durant les essais, de créer un processus d'analyse sous automatisation et contrôle de qualité visant à éviter les erreurs humaines, et de fournir un logiciel d'analyse pour conduire l'évaluation et livrer une piste de vérification.

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