Health Economic Evaluation of Primovist-enhanced Liver MRI

Phase 4

Completed

• Conditions: Colorectal Neoplasms; Neoplasm Metastasis
• Interventions: Procedure: Extracellular contrast media (ECCM) MRI; Procedure: Primovist MRI; Procedure: Contrast-enhanced CT

• Registration Number: NCT00764621
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Primary Completion: 2010-09
• Study Completion: 2010-11
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Patients with known or suspected metachronous liver metastases secondary to colorectal cancer who are scheduled for further contrast-enhanced tomographic imaging

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Extracellular contrast media (ECCM) MRI	-
Arm 1	Primovist MRI	-
Arm 3	Contrast-enhanced CT	-

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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