Health Economic Evaluation of Primovist-enhanced Liver MRI

November 3, 2014 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
      • Wien, Austria, 1030
      • Wien, Austria, 1090
  • Germany
      • Berlin, Germany, 10117
    • Baden-Württemberg
      • Karlsruhe, Baden-Württemberg, Germany, 76133
      • Tübingen, Baden-Württemberg, Germany, 72076
    • Bayern
      • München, Bayern, Germany, 81675
      • München, Bayern, Germany, 81377
    • Hessen
      • Frankfurt, Hessen, Germany, 60596
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17489
    • Nordrhein-Westfalen
      • Dortmund, Nordrhein-Westfalen, Germany, 44137
      • Dortmund, Nordrhein-Westfalen, Germany, 44263
    • Sachsen
      • Dresden, Sachsen, Germany, 01067
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39112
  • Italy
      • Ancona, Italy, 60126
      • Bologna, Italy, 40138
      • Brescia, Italy, 25100
      • Chieti, Italy, 66100
      • Napoli, Italy, 80138
    • Torino
      • Candiolo, Torino, Italy, 10060
  • Korea, Republic of
      • Hwasun, Korea, Republic of, 519809
      • Jeonbuk, Korea, Republic of, 561-712
      • Seoul, Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 135-710
    • Korea
      • Seoul,, Korea, Korea, Republic of, 152-703
    • South Korea
      • Gyeunggi-do, South Korea, Korea, Republic of, 463-707
  • Netherlands
      • Amsterdam, Netherlands, 1066CX
      • Leiden, Netherlands, 2333 ZA
      • Utrecht, Netherlands, 3584 CX
  • Spain
      • Barcelona, Spain, 08036
      • Sevilla, Spain, 41013
    • Canarias
      • Santa Cruz de Tenerife, Canarias, Spain, 38009
  • Sweden
      • Stockholm, Sweden, 17176
      • Stockholm, Sweden, 182 88
      • Uppsala, Sweden, 75185
  • Switzerland
      • Bern, Switzerland, 3010
      • Genève, Switzerland, 1211
      • Luzern, Switzerland, 6000
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
    • Sankt Gallen
      • St. Gallen, Sankt Gallen, Switzerland, 9007
  • Thailand
      • Bangkok, Thailand, 10700
      • Songkhla, Thailand, 90110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Experimental: Arm 1
Procedure: Primovist MRI
Contrast-enhanced MRI with an i.v. application of Primovist 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
At end of the study (per patient)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
After end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

October 1, 2008

First Submitted That Met QC Criteria

October 1, 2008

First Posted (Estimate)

October 2, 2008

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91789
  • 312041 (Other Identifier: company internal)
  • 2008-000583-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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