Health Economic Evaluation of Primovist-enhanced Liver MRI

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Colorectal Neoplasms, Neoplasm Metastasis

Intervention / Treatment
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* Procedure: Primovist MRI
* Procedure: Extracellular contrast media (ECCM) MRI
* Procedure: Contrast-enhanced CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Procedure: Primovist MRI<br>* Contrast-enhanced MRI with an i.v. application of Primovist in the approved dosage<br>|
| Active Comparator: Arm 2<br> | Procedure: Extracellular contrast media (ECCM) MRI<br>* Contrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage<br>|
| Active Comparator: Arm 3<br> | Procedure: Contrast-enhanced CT<br>* Contrast-enhanced 3 phase multidetector CT with an i.v. application of an approved iodinated contrast medium in the approved dosage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | At end of the study (per patient) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gadolinium ethoxybenzyl DTPA, Contrast media, Outcome Assessment (Health Care), Magnetic Resonance Imaging, Tomography, X-Ray Computed, Liver