Trial Condition(s):

Magnetic Resonance Imaging

Gadobutrol Magnevist-controlled Body Study

Bayer Identifier:

13297

ClinicalTrials.gov Identifier:

NCT01050829

EudraCT Number:

Not Available

Study Completed

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.

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

Trial Summary

Enrollment Goal
370
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Kameda Clinic

Kamogawa, Japan, 296-0041

Status
Completed
 
Locations

Juntendo University Juntendo Hospital

Bunkyo-ku, Japan, 113-8431

Status
Completed
 
Locations

Institute of Biomedical Research and Innovation

Kobe, Japan, 650-0047

Status
Completed
 
Locations

Shikoku Cancer Center

Matsuyama, Japan, 791-0280

Status
Completed
 
Locations

Harasanshin Hospital

Fukuoka, Japan, 812-0033

Status
Completed
 
Locations

1st Affiliated Hosp., 4th Military Med Univ.

Xi'an, China, 710032

Status
Completed
 
Locations

The 6th People's Hospital of Shanghai Jiao Tong University

Shanghai, China, 200233

Status
Completed
 
Locations

St. Mary Hospital

Seoul, South Korea, 150-713

Status
Completed
 
Locations

Shizuoka Cancer Center

Sunto, Japan, 411-8777

Status
Completed
 
Locations

Saiseikai Futsukaichi Hospital

Chikushino, Japan, 818-8516

Status
Completed
 
Locations

Chinese PLA General Hosp.

Beijing, China, 100853

Status
Completed
 
Locations

Zhongshan Hospital Fudan University.

Shanghai, China, 200032

Status
Completed
 
Locations

Tumor Hospital, Fudan University

Shanghai, China, 200032

Status
Completed
 
Locations

1st Affiliated hospital of Soochow University

Suzhou, China, 215006

Status
Completed
 
Locations

Zhongda Hosp. affiliated of Southeast Univ.

Nanjing, China, 210009

Status
Completed
 
Locations

Ewha Womans University Hospital

Seoul , South Korea, 158-710

Status
Completed
 

Trial Design