check_circleStudy Completed

Magnetic Resonance Imaging

Bayer Identifier:

13297

ClinicalTrials.gov Identifier:

NCT01050829

EudraCT Number:

Not Available

EU CT Number:

Not Available
Gadobutrol Magnevist-controlled Body Study

Trial 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.

Key Participants Requirements

Sex

Both

Age

20 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
370
Trial Dates
January 2010 - April 2011
Phase
Phase 3
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kameda ClinicKamogawa, 296-0041, Japan
Completed
Juntendo University Juntendo HospitalBunkyo-ku, 113-8431, Japan
Completed
Institute of Biomedical Research and InnovationKobe, 650-0047, Japan
Completed
Shikoku Cancer CenterMatsuyama, 791-0280, Japan
Completed
Harasanshin HospitalFukuoka, 812-0033, Japan
Completed
1st Affiliated Hosp., 4th Military Med Univ.Xi'an, 710032, China
Completed
The 6th People's Hospital of Shanghai Jiao Tong UniversityShanghai, 200233, China
Completed
St. Mary HospitalSeoul, 150-713, Korea, Republic Of
Completed
Shizuoka Cancer CenterSunto, 411-8777, Japan
Completed
Saiseikai Futsukaichi HospitalChikushino, 818-8516, Japan
Completed
Chinese PLA General Hosp.Beijing, 100853, China
Completed
Zhongshan Hospital Fudan University.Shanghai, 200032, China
Completed
Tumor Hospital, Fudan UniversityShanghai, 200032, China
Completed
1st Affiliated hospital of Soochow UniversitySuzhou, 215006, China
Completed
Zhongda Hosp. affiliated of Southeast Univ.Nanjing, 210009, China
Completed
Ewha Womans University HospitalSeoul, 158-710, Korea, Republic Of
Completed
Institute of Biomedical Research and InnovationKobe, 650-0047, Japan

Primary Outcome

  • The total score of the following 3 visualization parameters is used for primary variable: Degree of contrast enhancement; Border delineation; Internal morphology.
    date_rangeTime Frame:
    At Day 0
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Sensitivity and specificity for the detection of malignant lesions
    date_rangeTime Frame:
    At Day 0
    enhanced_encryption
    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
    date_rangeTime Frame:
    At Day 0
    enhanced_encryption
    Safety Issue:
    no
  • Confidence in diagnosis
    date_rangeTime Frame:
    At Day 0
    enhanced_encryption
    Safety Issue:
    no

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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