Multi-center, randomized comparison study to eVALUatE outcomes and resource needs of imaging and treatment following Primovist-enhanced MRI of the liver in comparison to extracellular contrast media (...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-000583-16

Multi-center, randomized comparison study to eVALUatE outcomes and resource needs of imaging and treatment following Primovist-enhanced MRI of the liver in comparison to extracellular contrast media (ECCM)-enhanced MRI and contrast-enhanced computed tomography (CT) in patients with a history of colorectal cancer and known or suspected metachronous liver metastases

Femme et Homme

  • | Pays :
  • -
  • | Organes :
  • -
  • | Spécialités :
  • -

Extrait

The main objective of this study is to evaluate outcomes and resource needs of imaging and treatment following Primovist-enhanced MRI (PV-MRI) as compared to ECCM-enhanced MRI (ECCM-MRI) and contrast-enhanced CT (CE-CT) in patients with a history of colorectal cancer and known or suspected metachronous liver metastases based on the evaluation of the following: • Proportion of patients for whom further imaging is required to come to a therapy decision after initial imaging of the liver with either PV-MRI, ECCM-MRI or CE-CT (primary efficacy variable) • Proportion of patients with intra-operatively modified surgical plans based on either PV-MRI, ECCM-MRI or CE-CT • Diagnostic performance of either PV-MRI, ECCM-MRI or CE-CT in comparison to final diagnosis • Confidence in diagnosis and therapeutic decision • Resource needs for imaging and treatment after either PV-MRI, ECCM-MRI or CE-CT


Critère d'inclusion

  • Patients with history of colorectal cancer and known or suspected metachronous liver metastasis(es) scheduled to undergo contrast-enhanced tomographic imaging (i.e. CE-MRI or CE-CT) of the liver