Gadobutrol Magnevist-controlled Body Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01050829
First received: January 13, 2010
Last updated: April 14, 2013
Last verified: April 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity and specificity for the detection of malignant lesions [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Confidence in diagnosis [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]

Enrollment: 371
Study Start Date: January 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050829

Locations
China, Jiangsu
Nanjing, Jiangsu, China, 210009
Suzhou, Jiangsu, China, 215006
China, Shanxi
Xi'an, Shanxi, China, 710032
China
Beijing, China, 100853
Shanghai, China, 200032
Shanghai, China, 200233
Japan
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, 158-710
Seoul, Korea, Republic of, 150-713
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01050829     History of Changes
Other Study ID Numbers: 13297
Study First Received: January 13, 2010
Last Updated: April 14, 2013
Health Authority: China: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency
Republic of Korea: Korean Food and Drug Administration

Keywords provided by Bayer:
Magnetic resonance imaging
Tumor
Contrast media
Gadobutrol

Additional relevant MeSH terms:
Gadolinium DTPA
Gadobenic acid
Gadobutrol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014