A Study Comparing Two Magnetic Resonance Imaging (MRI) Co... | NCT00323102

Studies
A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain

NCT00323102

Sponsor

Bracco Diagnostics, Inc

Status

Completed

Last Update Posted

Jan 23, 2008Estimated

Enrollment

114

Phase

Phase 4

Conditions

Brain Pathology

Interventions

Multihance

Countries

United States

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

Jan 2008

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

May 2006

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

May 5, 2006

First Submission Date that Met QC Criteria

May 5, 2006

First Posted Date

May 9, 2006Estimated

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

Jan 18, 2008

Last Update Posted Date

Jan 23, 2008Estimated

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

This study aims at a direct comparison between Multihance and a validated comparator like Omniscan in a cross-over individual design in patients with brain tumors to confirm the superior overall diagnostic performance of MuliHance for this indication

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114

Name	Type	Description	Arm Group Labels	Other Names
Multihance	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Superiority of Multihance in terms of by-patient global diagnostic performance		immediately post dose

Secondary Outcomes

Measure	Description	Time Frame
To compare the two products in terms of by patients global performance for border delineation of lesions; contrast of lesions		immediately post dose
To compare the two products in terms of global changes in lesion count; To compare the two products in terms of changes from pre to post dose in signal intensity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 yrs of age or older; provide written informed consent; scheduled to undergo MRI; willing to undergo 2 MRI exams within 14 days

Exclusion Criteria:

Known allergy to one or more ingredients in the test agents; severe CHF (Class IV); suffered stroke one year ago; pregnancy or lactating females; contraindications to MRI; severe claustrophobia; scheduled to receive surgery prior to or between the two MRI exams, or steroids or radiosurgery between the two MRI exams

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barry Hogstrom, M. D.	Bracco Diagnostics, Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bracco Diagnostics, Inc.		Princeton	New Jersey	08540	United States

Intervention Browse Module

MeSH Terms

ID	Term
C064572	gadobenic acid

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided