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Health Economic Evaluation of Primovist-enhanced Liver MRI

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00764621
First received: October 1, 2008
Last updated: December 17, 2012
Last verified: December 2012
History of Changes

October 1, 2008
December 17, 2012
October 2008
September 2010   (final data collection date for primary 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. [ Time Frame: At end of the study (per patient) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00764621 on ClinicalTrials.gov Archive Site
Proportion of patients with intra-operatively modified surgical plans based on initial imaging with either Primovist-, ECCM-MRI or CE-CT [ Time Frame: After end of the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • 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
  • Experimental: Arm 1
    Intervention: Procedure: Primovist MRI
  • Active Comparator: Arm 2
    Intervention: Procedure: Extracellular contrast media (ECCM) MRI
  • Active Comparator: Arm 3
    Intervention: Procedure: Contrast-enhanced CT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
361
November 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Italy,   Korea, Republic of,   Netherlands,   Spain,   Sweden,   Switzerland,   Thailand
 
NCT00764621
91789, 312041, 2008-000583-16
No
Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP