Gadobutrol Magnevist-controlled Body Study | NCT01050829

Studies
Gadobutrol Magnevist-controlled Body Study

NCT01050829

Sponsor

Bayer

Status

Completed

Last Update Posted

Dec 30, 2014Estimated

Enrollment

370Actual

Phase

Phase 3

Conditions

Magnetic Resonance Imaging

Interventions

Gadobutrol (Gadovist, BAY86-4875)
Gadopentetate Dimeglumine (Magnevist, BAY86-4882)

Countries

China
Japan
South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Jan 13, 2010

First Submission Date that Met QC Criteria

Jan 14, 2010

First Posted Date

Jan 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2014

Last Update Posted Date

Dec 30, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

370Actual

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Gadobutrol (Gadovist, BAY86-4875)
Arm 2	Active Comparator		Drug: Gadopentetate Dimeglumine (Magnevist, BAY86-4882)

Name	Type	Description	Arm Group Labels	Other Names
Gadobutrol (Gadovist, BAY86-4875)	Drug	Single administration at a dose of 0.1 mmol/kg	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The total score of the following 3 visualization parameters is used for primary variable: Degree of contrast enhancement; Border delineation; Internal morphology.		At Day 0

Secondary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity for the detection of malignant lesions		At Day 0
Exact match of the MR diagnosis with the final clinical diagnosis based on medical records up until 3 months after the scan		At Day 0

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Nanjing	Jiangsu	210009	China

ID	Term
C090600	gadobutrol
D019786	Gadolinium DTPA

ID	Term
D004369	Pentetic Acid
D011073	Polyamines
D000588	Amines
D009930	Organic Chemicals