NCT00905879

Brief Summary

Patients will be recruited from those who will undergo contrast enhanced MRI. Safety and tolerability will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2009

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

First Submitted

Initial submission to the registry

April 27, 2009

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 26, 2013

Status Verified

April 1, 2013

First QC Date

April 27, 2009

Last Update Submit

April 25, 2013

Conditions

Magnetic Resonance Imaging

Keywords

Magnetic Resonance Imaging (MRI)Observational studyGadobutrol

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measures would be safety and tolerability of Gadovist which would be measured by change in Vital signs before and after the procedure and the occurrence of serious or non-serious adverse events

    Up to 1 hour after MRI

Other Outcomes (2)

  • Magnetic field strength of MRI

    During the procedure

  • Volume of contrast agent used

    During the procedure

Study Arms (1)

Group 1

Drug: Gadobutrol (Gadovist, BAY86-4875)

Interventions

Gadobutrol (Gadovist, BAY86-4875)DRUG

Patients who will need to undergo contrast enhanced MRI with gadobutrol (Gadovist)

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 18 years old and above who will undergo contrast enhanced MRI with Gadobutrol (Gadovist)

You may qualify if:

  • years old and above undergoing contrast enhanced cranial or spinal MRI with Gadobutrol (Gadovist)

You may not qualify if:

  • History of hypersensitivity reaction to gadolinium containing contrast material
  • Hypersensitivity to any of the ingredients of Gadobutrol (Gadovist)
  • History of hypersensitivity to any other contrast agent
  • Patients with uncorrected hypokalemia
  • Pregnant and lactating women
  • Patients with severe cardiovascular diseases
  • Patients in whom MRI cannot be performed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Philippines

Location

MeSH Terms

Interventions

gadobutrol

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 27, 2009

First Posted

May 21, 2009

Study Start

June 1, 2009

Study Completion

January 1, 2011

Last Updated

April 26, 2013

Record last verified: 2013-04

Locations

PH(1)