check_circleStudy Completed

Central nervous system diseases

Bayer Identifier:

91536

ClinicalTrials.gov Identifier:

NCT00395460

EudraCT Number:

Not Available

EU CT Number:

Not Available
Efficacy and safety study to evaluate Gadavist (Gadobutrol) as contrast agent in Magnetic Resonance Imaging (MRI) of brain or spine diseases in Chinese patients

Trial purpose

The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - Chinese origin, with known or suspected brain or spine diseases
  • - Pregnancy
    - Lactation
    - Conditions interfering with MRI
    - Allergy to any contrast agent or any drugs
    - Participation in other trial
    - Require emergency treatment
    - Severely impaired liver and kidney functions

Trial summary

Enrollment Goal
147
Trial Dates
September 2006 - April 2007
Phase
Phase 3
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Shanghai, 200040, China
Completed
Beijing, 100853, China
Completed
Nanjing, 210029, China
Completed
The 1st Affiliated Hosp of the 4th Military Med UniXi'an, 710032, China

Primary Outcome

  • Change in contrast to noise ratio (CNR) between pre- and post-contrast MRI scan of CNS lesions
    date_rangeTime Frame:
    Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Change in number of detected lesions from pre- to post-contrast MRI scan
    date_rangeTime Frame:
    Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
    enhanced_encryption
    Safety Issue:
    None
  • Change in diagnostic confidence from pre- to post-contrast MRI by treatment
    date_rangeTime Frame:
    Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
    enhanced_encryption
    Safety Issue:
    None
  • Change in lesion contrast enhancement from pre- to post-contrast MRI
    date_rangeTime Frame:
    Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
    enhanced_encryption
    Safety Issue:
    None
  • Change in lesion delineation between pre- and post-contrast MRI scan of CNS lesions
    date_rangeTime Frame:
    Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
    enhanced_encryption
    Safety Issue:
    None

Trial design

A single-blind, multicenter, randomized, phase III study of the efficacy and safety of Gadavist (1.0 M) in comparison with Magnevist (0.5 M) as contrast agent for enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) lesions in Chinese patients
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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