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Brief Title: Health Economic Evaluation of Primovist-enhanced Liver MRI
Official Title: 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.
Study ID: NCT00764621
Brief Summary: Patients with a history of colorectal cancer and known or suspected liver metastases who are scheduled for contrast-enhanced tomographic imaging will be included in this study. After randomization to either Primovist-enhanced MRI, extracellular contrast media (ECCM)-enhanced MRI or contrast-enhanced (CE)-CT outcomes and resource needs of the diagnostic work-up and treatment will be evaluated for each of the three imaging modalities. Main objectives of the study are to assess the proportion of patients for whom further imaging is required to come to a therapy decision and to evaluate the proportion of patients with intraoperatively modified surgical plans after Primovist-enhanced MRI as compared to ECCM-enhanced MRI and CE-CT.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Graz, , Austria
, Wien, , Austria
, Wien, , Austria
, Karlsruhe, Baden-Württemberg, Germany
, Tübingen, Baden-Württemberg, Germany
, München, Bayern, Germany
, München, Bayern, Germany
, Frankfurt, Hessen, Germany
, Greifswald, Mecklenburg-Vorpommern, Germany
, Dortmund, Nordrhein-Westfalen, Germany
, Dortmund, Nordrhein-Westfalen, Germany
, Magdeburg, Sachsen-Anhalt, Germany
, Dresden, Sachsen, Germany
, Berlin, , Germany
, Candiolo, Torino, Italy
, Ancona, , Italy
, Bologna, , Italy
, Brescia, , Italy
, Chieti, , Italy
, Napoli, , Italy
, Seoul,, Korea, Korea, Republic of
, Gyeunggi-do, South Korea, Korea, Republic of
, Hwasun, , Korea, Republic of
, Jeonbuk, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Amsterdam, , Netherlands
, Leiden, , Netherlands
, Utrecht, , Netherlands
, Santa Cruz de Tenerife, Canarias, Spain
, Barcelona, , Spain
, Sevilla, , Spain
, Stockholm, , Sweden
, Stockholm, , Sweden
, Uppsala, , Sweden
, Basel, Basel-Stadt, Switzerland
, St. Gallen, Sankt Gallen, Switzerland
, Bern, , Switzerland
, Genève, , Switzerland
, Luzern, , Switzerland
, Bangkok, , Thailand
, Songkhla, , Thailand
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR