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 (...

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Reference: 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

Woman and Man

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Extract

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


Inclusion criteria

  • 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