MedTrace Logo

Health Economic Evaluation of Primovist-enhanced Liver MRI

NCT00764621 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2014-11-04

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-09-30
Completion
2010-11-30

Countries

  • Austria
  • Germany
  • Italy
  • Netherlands
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Thailand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00764621 on ClinicalTrials.gov