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Health Economic Evaluation of Primovist-Enhanced Liver MRI

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase IV Diagnostic, Health services research Approved-not yet active 18 and over Pharmaceutical / Industry 91789
312041, NCT00764621

Trial Description

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.

Eligibility Criteria

Inclusion Criteria:

Patients with known or suspected metachronous liver metastases secondary to colorectal cancer who are scheduled for further contrast-enhanced tomographic imaging

Exclusion Criteria:

Patients (men or women) under 18 years of age

Patients who have received any contrast material within 24 hours before injection of study drug, or who are scheduled to receive any contrast material within 24 hours after injection

Patients not eligible to contrast media (CM) injection according to product labeling

Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test at baseline visit(s)

Patients scheduled for liver-specific MRI other than Primovist-enhanced MRI, i.e. Multihance-, Teslascan- or SPIO-enhanced MRI

Patients who are clinically unstable and whose clinical course is unpredictable (e.g. due to previous surgery, acute myocardial infarction)

Patients with known anaphylactoid or anaphylactic reaction to any contrast media or hypersensitivity to any allergen including drugs

Patients with a contraindication for MRI or CT.

Patients with impaired renal function (e.g. acute renal failure) or patients on dialysis

Trial Contact Information

Trial Lead Organizations/Sponsors

Bayer Corporation

Bayer Study Director

Study Director

Bayer Clinical Trials Contact
		Email: clinical-trials-contact@bayerhealthcare.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00764621
Information obtained from ClinicalTrials.gov on October 02, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.