Health Economic Evaluation of Primovist-enhanced Liver MRI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00764621
First received: October 1, 2008
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 361
Study Start Date: October 2008
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764621

  Show 44 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00764621     History of Changes
Other Study ID Numbers: 91789, 312041, 2008-000583-16
Study First Received: October 1, 2008
Last Updated: December 11, 2013
Health Authority: Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Korea: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Thailand: Food and Drug Administration

Keywords provided by Bayer:
Gadolinium ethoxybenzyl DTPA
Contrast media
Outcome Assessment (Health Care)
Magnetic Resonance Imaging
Tomography, X-Ray Computed
Liver

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
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
Contrast Media
Gadolinium ethoxybenzyl DTPA
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014