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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.


Phase 4
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms, Neoplasm Metastasis

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Trial Information

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.


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 severe renal impairment (eGFR < 30ml/min/1.73m2) or patients on
dialysis

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Primary variable is the proportion of patients in each of the three treatment groups for whom further imaging is required after initial imaging to come to a therapy decision.

Outcome Time Frame:

At end of the study (per patient)

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

91789

NCT ID:

NCT00764621

Start Date:

October 2008

Completion Date:

November 2010

Related Keywords:

  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Gadolinium ethoxybenzyl DTPA
  • Contrast media
  • Outcome Assessment (Health Care)
  • Magnetic Resonance Imaging
  • Tomography, X-Ray Computed
  • Liver
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis

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