Contrast Enhanced MRI of the CNS - Patients With Known Ce... | NCT00764387

Studies
Contrast Enhanced MRI of the CNS - Patients With Known Cerebral Neoplastic Lesions.

NCT00764387

Sponsor

Bayer

Status

Completed

Last Update Posted

Dec 5, 2014Estimated

Enrollment

166Actual

Phase

Phase 4

Conditions

Neoplastic CNS Lesions

Interventions

Gadovist® (Gadobutrol, BAY86-4875)
Dotarem

Countries

Italy

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

ID	Type	Description	Link
2007-005693-31	EudraCT Number
312021	Other Identifier	Company Internal

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

Mar 2008

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Jul 3, 2008

First Submission Date that Met QC Criteria

Oct 1, 2008

First Posted Date

Oct 2, 2008Estimated

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 4, 2014

Last Update Posted Date

Dec 5, 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

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

166Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Gadovist® (Gadobutrol, BAY86-4875)
Arm 2	Active Comparator		Drug: Dotarem

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gadovist® (Gadobutrol, BAY86-4875)	Drug	0,1 mmol/kg of body weight in the vein, single administration	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary analysis will be the comparison of the enhancements characteristics of Gadobutrol and Gd-TOTA on a lesion per lesion basis.		October 2007 to November 2008

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Known neoplastic CNS lesions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

References Module

Citations

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Andria	Bari	70031	Italy

ID	Term
C090600	gadobutrol
C072417	gadoterate meglumine