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Health Economic Evaluation of Primovist-enhanced Liver MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00764621
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : November 4, 2014
Information provided by (Responsible Party):

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 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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Neoplasm Metastasis Procedure: Primovist MRI Procedure: Extracellular contrast media (ECCM) MRI Procedure: Contrast-enhanced CT Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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.
Study Start Date : October 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1 Procedure: Primovist MRI
Contrast-enhanced MRI with an i.v. application of Primovist in the approved dosage

Active Comparator: Arm 2 Procedure: Extracellular contrast media (ECCM) MRI
Contrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage

Active Comparator: Arm 3 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

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00764621

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Graz, Austria, 8036
Wien, Austria, 1030
Wien, Austria, 1090
Karlsruhe, Baden-Württemberg, Germany, 76133
Tübingen, Baden-Württemberg, Germany, 72076
München, Bayern, Germany, 81377
München, Bayern, Germany, 81675
Frankfurt, Hessen, Germany, 60596
Greifswald, Mecklenburg-Vorpommern, Germany, 17489
Dortmund, Nordrhein-Westfalen, Germany, 44137
Dortmund, Nordrhein-Westfalen, Germany, 44263
Magdeburg, Sachsen-Anhalt, Germany, 39112
Dresden, Sachsen, Germany, 01067
Berlin, Germany, 10117
Candiolo, Torino, Italy, 10060
Ancona, Italy, 60126
Bologna, Italy, 40138
Brescia, Italy, 25100
Chieti, Italy, 66100
Napoli, Italy, 80138
Korea, Republic of
Seoul,, Korea, Korea, Republic of, 152-703
Gyeunggi-do, South Korea, Korea, Republic of, 463-707
Hwasun, Korea, Republic of, 519809
Jeonbuk, Korea, Republic of, 561-712
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of
Amsterdam, Netherlands, 1066CX
Leiden, Netherlands, 2333 ZA
Utrecht, Netherlands, 3584 CX
Santa Cruz de Tenerife, Canarias, Spain, 38009
Barcelona, Spain, 08036
Sevilla, Spain, 41013
Stockholm, Sweden, 17176
Stockholm, Sweden, 182 88
Uppsala, Sweden, 75185
Basel, Basel-Stadt, Switzerland, 4031
St. Gallen, Sankt Gallen, Switzerland, 9007
Bern, Switzerland, 3010
Genève, Switzerland, 1211
Luzern, Switzerland, 6000
Bangkok, Thailand, 10700
Songkhla, Thailand, 90110
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT00764621    
Other Study ID Numbers: 91789
312041 ( Other Identifier: company internal )
2008-000583-16 ( EudraCT Number )
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014
Keywords provided by Bayer:
Gadolinium ethoxybenzyl DTPA
Contrast media
Outcome Assessment (Health Care)
Magnetic Resonance Imaging
Tomography, X-Ray Computed
Additional relevant MeSH terms:
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Neoplasm Metastasis
Colorectal Neoplasms
Neoplastic Processes
Pathologic Processes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases