Gadobutrol Magnevist-controlled Body Study

Study Overview
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Brief Summary
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The purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the body/extremities regions. The results of the MRI with gadobutrol injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with Magnevist.

Official Title
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A Multi-center/Multi-national, Randomized, Controlled, Single-blind, Group Comparison Phase 3 Study to Determine the Efficacy and Safety of Gadobutrol 1.0 Molar in Comparison to Magnevist Following Single Injection in Patients Referred for Contrast-enhanced MRI of the Body/Extremities Regions (Breast, Heart, Abdomen, Kidney, Pelvis, or Extremities)

Conditions
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Magnetic Resonance Imaging

Intervention / Treatment
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* Drug: Gadobutrol (Gadovist, BAY86-4875)
* Drug: Gadopentetate Dimeglumine (Magnevist, BAY86-4882)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 20 years of age Is referred for a contrast-enhanced MRI of the body/extremities based on current clinical symptoms or results of a previous imaging procedure Is willing to undergo the routine contrast-enhanced MRI examinations Is willing and able to complete all study procedures specified in the protocol Subject is male, or is female not of childbearing potential, or is female of childbearing potential who is using any medically accepted means of contraception and has a negative urine pregnancy test prior to the administration of gadobutrol or Magnevist Exclusion Criteria: Is a female subject who is pregnant or nursing Has received any investigational product or has participated in any other clinical trial within 2 weeks prior to enrolling in this study Has been previously enrolled in this study or any other study using gadobutrol Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents Has received any contrast agent within 24 hours prior to the study MRI Has a glomerular filtration rate value <30 mL/min/1.73m2 derived from a serum creatinine result within 4 weeks prior to study enrollment Is considered clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure) Has severe cardiovascular disease (eg, acute myocardial infarction (<14 days), unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (<48 hours) Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period Has any contraindication to Magnevist according to the package insert

Ages Eligible for Study
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Minimum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Gadobutrol (Gadovist, BAY86-4875)<br>* Single administration at a dose of 0.1 mmol/kg<br>|
| Active Comparator: Arm 2<br> | Drug: Gadopentetate Dimeglumine (Magnevist, BAY86-4882)<br>* Single administration at a dose of 0.1 mmol/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total score of the following 3 visualization parameters is used for primary variable: Degree of contrast enhancement; Border delineation; Internal morphology. |  | At Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity for the detection of malignant lesions |  | At Day 0 | 
| Exact match of the MR diagnosis with the final clinical diagnosis based on medical records up until 3 months after the scan |  | At Day 0 | 
| Confidence in diagnosis |  | At Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic resonance imaging, Tumor, Contrast media, Gadobutrol