Status:
COMPLETED
Health Economic Evaluation of Primovist-enhanced Liver MRI
Lead Sponsor:
Bayer
Conditions:
Colorectal Neoplasms
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- Patients with known or suspected metachronous liver metastases secondary to colorectal cancer who are scheduled for further contrast-enhanced tomographic imaging
Exclusion
- 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 severe renal impairment (eGFR \< 30ml/min/1.73m2) or patients on dialysis
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00764621
Start Date
October 1 2008
End Date
November 1 2010
Last Update
November 4 2014
Active Locations (44)
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1
Vienna, Vienna, Austria, 1090
2
Graz, Austria, 8036
3
Vienna, Austria, 1030
4
Karlsruhe, Baden-Wurttemberg, Germany, 76133