Study 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

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

January 2010 - April 2011

Phase

Phase 3

Could I Receive a placebo

Products

Gadavist/Gadovist (Gadobutrol, BAY86-4875)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Kameda Clinic	Kamogawa, 296-0041, Japan
Completed	Juntendo University Juntendo Hospital	Bunkyo-ku, 113-8431, Japan
Completed	Institute of Biomedical Research and Innovation	Kobe, 650-0047, Japan
Completed	Shikoku Cancer Center	Matsuyama, 791-0280, Japan
Completed	Harasanshin Hospital	Fukuoka, 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 University	Shanghai, 200233, China
Completed	St. Mary Hospital	Seoul, 150-713, Korea, Republic Of
Completed	Shizuoka Cancer Center	Sunto, 411-8777, Japan
Completed	Saiseikai Futsukaichi Hospital	Chikushino, 818-8516, Japan
Completed	Chinese PLA General Hosp.	Beijing, 100853, China
Completed	Zhongshan Hospital Fudan University.	Shanghai, 200032, China
Completed	Tumor Hospital, Fudan University	Shanghai, 200032, China
Completed	1st Affiliated hospital of Soochow University	Suzhou, 215006, China
Completed	Zhongda Hosp. affiliated of Southeast Univ.	Nanjing, 210009, China
Completed	Ewha Womans University Hospital	Seoul, 158-710, Korea, Republic Of
Completed	Institute of Biomedical Research and Innovation	Kobe, 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.
Time Frame:
At Day 0
Safety Issue:
no

Secondary Outcome

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

Additional Information

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