NCT01660841

Brief Summary

Purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking images of the brain and spine. The results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images taken without contrast (gadobutrol).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

15 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

First Submitted

Initial submission to the registry

August 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

August 7, 2012

Last Update Submit

September 30, 2014

Conditions

Magnetic Resonance Imaging

Keywords

Magnetic resonance imagingcentral nervous systemcontrast mediagadobutrol

Outcome Measures

Primary Outcomes (4)

  • Scores for visualization parameter: degree of contrast enhancement

    Blinded readers evaluate contrast of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.

    Day of gadobutrol injection (Day 0)

  • Scores for visualization parameter: border delineation

    Blinded readers evaluate border delineation of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.

    Day of gadobutrol injection (Day 0)

  • Scores for visualization parameter: internal morphology

    Blinded readers evaluate internal morphology of at maximum 5 lesions and 4 normal structures in scans taken with and without gadobutrol on a 3-point-scale.

    Day of gadobutrol injection (Day 0)

  • Number of detected lesions

    Blinded readers determine number of detected lesions in scans with and without gadobutrol.

    Day of gadobutrol injection (Day 0)

Secondary Outcomes (4)

  • Percentage of exact match of the MRI diagnosis with the final clinical diagnosis

    Day of gadobutrol injection (Day 0)

  • Sensitivity and specificity to detect abnormal/normal brain tissue

    Day of gadobutrol injection (Day 0)

  • Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions

    Day of gadobutrol injection (Day 0)

  • Number of participants with treatment emergent adverse events as a measure of safety and tolerability

    3 days after injection (Day 3)

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Gadobutrol (Gadovist, BAY86-4875)

Interventions

Gadobutrol (Gadovist, BAY86-4875)DRUG

A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Subjects referred for a contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system based on current clinical symptoms or results of a previous imaging procedure

You may not qualify if:

  • Subjects with any contraindication to the MRI examination
  • Subjects with severe renal disease to end stage renal disease
  • Subjects scheduled or are likely to require a biopsy or any interventional therapeutic procedure within 72 (±4) hours after the study MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Nagoya, Aichi-ken, 455-8530, Japan

Location

Unknown Facility

Funabashi, Chiba, 274-8503, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 810-0001, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 811-0213, Japan

Location

Unknown Facility

Kitakyushu, Fukuoka, 800-0057, Japan

Location

Unknown Facility

Fukuyama, Hiroshima, 720-0825, Japan

Location

Unknown Facility

Kobe, Hyōgo, 650-0047, Japan

Location

Unknown Facility

Kobe, Hyōgo, 654-0047, Japan

Location

Unknown Facility

Fujisawa, Kanagawa, 251-8550, Japan

Location

Unknown Facility

Kawasaki, Kanagawa, 210-0013, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 226-0025, Japan

Location

Unknown Facility

Daitō, Osaka, 574-0074, Japan

Location

Unknown Facility

Kishiwada, Osaka, 596-8522, Japan

Location

Unknown Facility

Shimonoseki, Yamaguchi, 750-0061, Japan

Location

Unknown Facility

Ube, Yamaguchi, 755-0151, Japan

Location

MeSH Terms

Interventions

gadobutrol

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 9, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 1, 2014

Record last verified: 2014-09

Locations

JP(15)