NCT02540967

Brief Summary

The objectives of this study are to investigate the safety and effectiveness of Gadovist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,357

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

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

September 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 27, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2017

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

September 2, 2015

Last Update Submit

November 6, 2023

Conditions

Magnetic Resonance ImagingImage Enhancement

Keywords

Contrast enhancement in the following MR imagingBrain and spineBody and extremitiesGadobutrol

Outcome Measures

Primary Outcomes (1)

  • Number of episodes of adverse events as a measure of safety and tolerability

    Up to 3 days

Secondary Outcomes (2)

  • Number of episodes of adverse drug reactions and adverse events

    Up to 3 days

  • Contrast enhancement

    At the time of MRI

Study Arms (1)

BAY86-4875

Gadovist administration goup

Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)

Interventions

Gadobutrol (Gadavist/Gadovist, BAY86-4875)DRUG

Gadovist dosage following summary of product characteristics

BAY86-4875

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female and male patients who planned Gd contrast enhanced MRI in accordance with approved label. Eligible patients who receive Gadovist will be enrolled and documented in the eCRF

You may qualify if:

  • Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist.

You may not qualify if:

  • Patients who are contraindicated based on approved label.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many Locations

Multiple Locations, Japan

Location

Related Publications (1)

  • Tsushima Y, Awai K, Shinoda G, Miyoshi H, Chosa M, Sunaya T, Endrikat J. Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan. Jpn J Radiol. 2018 Nov;36(11):676-685. doi: 10.1007/s11604-018-0778-4. Epub 2018 Sep 19.

    PMID: 30232584RESULT

Related Links

MeSH Terms

Interventions

gadobutrol

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2015

First Posted

September 4, 2015

Study Start

October 27, 2015

Primary Completion

November 2, 2017

Study Completion

November 2, 2017

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

JP(1)