Trial Condition(s):
Central nervous system diseases
Efficacy and safety study to evaluate Gadavist (Gadobutrol) as contrast agent in Magnetic Resonance Imaging (MRI) of brain or spine diseases in Chinese patients
Bayer Identifier:
91536
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Chinese origin, with known or suspected brain or spine diseases
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Shanghai, China, 200040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100853 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nanjing, China, 210029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The 1st Affiliated Hosp of the 4th Military Med Uni Xi'an, China, 710032 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Change in contrast to noise ratio (CNR) between pre- and post-contrast MRI scan of CNS lesionsTimeframe: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Secondary Outcome
- Change in number of detected lesions from pre- to post-contrast MRI scanTimeframe: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
- Change in diagnostic confidence from pre- to post-contrast MRI by treatmentTimeframe: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
- Change in lesion contrast enhancement from pre- to post-contrast MRITimeframe: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
- Change in lesion delineation between pre- and post-contrast MRI scan of CNS lesionsTimeframe: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Additional Information
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