Health Economic Evaluation of Primovist-enhanced Liver MRI

Colorectal Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764621
• Other study ID #: 91789
• Secondary ID: 3120412008-00058
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2008
• Last updated: November 3, 2014
• Start date: October 2008
• Est. completion date: November 2010

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareGermany: Federal Institute for Drugs and Medical DevicesItaly: Ministry of HealthKorea: Food and Drug AdministrationNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Spain: Spanish Agency of MedicinesSweden: Medical Products AgencySwitzerland: SwissmedicThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Procedure:
• Primovist MRI
Contrast-enhanced MRI with an i.v. application of Primovist in the approved dosage
• Extracellular contrast media (ECCM) MRI
Contrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage
• Contrast-enhanced CT
Contrast-enhanced 3 phase multidetector CT with an i.v. application of an approved iodinated contrast medium in the approved dosage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Germany,  Italy,  Korea, Republic of,  Netherlands,  Spain,  Sweden,  Switzerland,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		At end of the study (per patient)	No
Secondary	Proportion of patients with intra-operatively modified surgical plans based on initial imaging with either Primovist-, ECCM-MRI or CE-CT		After end of the study	No

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