NCT00764621

Health Economic Evaluation of Primovist-enhanced Liver MRI

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms
• Neoplasm Metastasis

Interventions

Type	Name	Description
PROCEDURE	Primovist MRI	Contrast-enhanced MRI with an i.v. application of Primovist in the approved dosage
PROCEDURE	Extracellular contrast media (ECCM) MRI	Contrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage
PROCEDURE	Contrast-enhanced CT	Contrast-enhanced 3 phase multidetector CT with an i.v. application of an approved iodinated contrast medium in the approved dosage

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2008-10-02
• Last updated: 2014-11-04

Locations

44 sites across 9 countries: Austria, Germany, Italy, Netherlands, South Korea, Spain, Sweden, Switzerland, Thailand