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Trial record 33 of 95 for:    gadobenate dimeglumine

Gadobutrol Magnevist-controlled Body Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01050829
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : December 30, 2014
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Magnetic Resonance Imaging Drug: Gadobutrol (Gadovist, BAY86-4875) Drug: Gadopentetate Dimeglumine (Magnevist, BAY86-4882) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: 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)
Study Start Date : January 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: Arm 1 Drug: Gadobutrol (Gadovist, BAY86-4875)
Single administration at a dose of 0.1 mmol/kg

Active Comparator: Arm 2 Drug: Gadopentetate Dimeglumine (Magnevist, BAY86-4882)
Single administration at a dose of 0.1 mmol/kg

Primary Outcome Measures :
  1. The total score of the following 3 visualization parameters is used for primary variable: Degree of contrast enhancement; Border delineation; Internal morphology. [ Time Frame: At Day 0 ]

Secondary Outcome Measures :
  1. Sensitivity and specificity for the detection of malignant lesions [ Time Frame: At Day 0 ]
  2. Exact match of the MR diagnosis with the final clinical diagnosis based on medical records up until 3 months after the scan [ Time Frame: At Day 0 ]
  3. Confidence in diagnosis [ Time Frame: At Day 0 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01050829

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China, Jiangsu
Nanjing, Jiangsu, China, 210009
Suzhou, Jiangsu, China, 215006
China, Shanxi
Xi'an, Shanxi, China, 710032
Beijing, China, 100853
Shanghai, China, 200032
Shanghai, China, 200233
Kamogawa, Chiba, Japan, 296-0041
Matsuyama, Ehime, Japan, 791-0280
Chikushino, Fukuoka, Japan, 818-8516
Kobe, Hyogo, Japan, 650-0047
Sunto, Shizuoka, Japan, 411-8777
Bunkyo-ku, Tokyo, Japan, 113-8431
Fukuoka, Japan, 812-0033
Korea, Republic of
Seoul, Korea, Republic of, 150-713
Seoul, Korea, Republic of, 158-710
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Therapeutic Area Head, Bayer Healthcare AG Identifier: NCT01050829     History of Changes
Other Study ID Numbers: 13297
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Magnetic resonance imaging
Contrast media