NCT00764387

Brief Summary

Study to compare of two contrast agents in imaging brain lesions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

1.2 years

First QC Date

July 3, 2008

Last Update Submit

December 4, 2014

Conditions

Neoplastic CNS Lesions

Keywords

Neoplastic CNS lesionsContrast enhanced MRIComparison

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Gadovist® (Gadobutrol, BAY86-4875)

Arm 2

ACTIVE COMPARATOR
Drug: Dotarem

Interventions

Gadovist® (Gadobutrol, BAY86-4875)DRUG

0,1 mmol/kg of body weight in the vein, single administration

Arm 1
DotaremDRUG

0,1 mmol/kg of body weight in the vein, single administration

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Known neoplastic CNS lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Andria, Bari, 70031, Italy

Location

Unknown Facility

Catania, 95126, Italy

Location

Unknown Facility

Chieti, 66013, Italy

Location

Unknown Facility

Messina, 98122, Italy

Location

Unknown Facility

Milan, 20132, Italy

Location

Unknown Facility

Napoli, 80131, Italy

Location

Unknown Facility

Novara, 28100, Italy

Location

Unknown Facility

Roma, 00133, Italy

Location

Unknown Facility

Roma, 00168, Italy

Location

Unknown Facility

Siena, 53100, Italy

Location

Unknown Facility

Trieste, 34149, Italy

Location

Unknown Facility

Verona, 37136, Italy

Location

Related Links

MeSH Terms

Interventions

gadobutrolgadoterate meglumine

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2008

First Posted

October 2, 2008

Study Start

March 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

IT(12)