NCT00411931

Brief Summary

Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

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

September 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 11, 2008

Status Verified

January 1, 2008

Enrollment Period

1.2 years

First QC Date

December 13, 2006

Last Update Submit

January 10, 2008

Conditions

Central Nervous System Pathology

Outcome Measures

Primary Outcomes (1)

  • Assess the blood PK of Multihance in patients from 2 to 5 years of age

    up to 24 hours post dose

Secondary Outcomes (1)

  • Evaluate the safety of Multihance in patients from 2 to 5 years of age

    through 72 hours post dose

Interventions

MultihanceDRUG

0.5M administered as a single injection

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female between 2 and 5 years of age
  • Obtained informed consent from patient's parent or guardian
  • Obtain assent when applicable according to local law
  • Known or suspected disease of the central nervous system (brain or spine)
  • Referred for MRI of the brain or spine requiring an injection of an MR contrast agent

You may not qualify if:

  • Contraindications to MR examination
  • Undergoing MRI in an emergency situation
  • Known allergy to one or more ingredients in the contrast agent or history of hypersensitivity to gadolinium or metals
  • Sickle cell anemia
  • Likely to undergo an invasive examination within 72 hours after administration of the investigational product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Krakow, Poland

Location

MeSH Terms

Interventions

gadobenic acid

Study Officials

  • Gianpaolo Pirovano, M. D.

    Bracco Diagnostics, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 13, 2006

First Posted

December 15, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 11, 2008

Record last verified: 2008-01

Locations

PL(1)