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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)


Phase 3
20 Years
N/A
Not Enrolling
Both
Magnetic Resonance Imaging

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome Measure:

The total score of the following 3 visualization parameters is used for primary variable: Degree of contrast enhancement; Border delineation; Internal morphology.

Outcome Time Frame:

At Day 0

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

China: Food and Drug Administration

Study ID:

13297

NCT ID:

NCT01050829

Start Date:

January 2010

Completion Date:

April 2011

Related Keywords:

  • Magnetic Resonance Imaging
  • Magnetic resonance imaging
  • Tumor
  • Contrast media
  • Gadobutrol

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