Trial Condition(s):
Vascular Diseases
Efficacy and safety study to evaluate Gadavist (Gadobutrol) as contrast agent in Magnetic Resonance Imaging (MRI) of vascular diseases in Chinese patients
Bayer Identifier:
91537
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 vascular diseases in patients of Chinese origin.
Inclusion Criteria
- Chinese origin - Known or suspected blood vessel 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 Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School Shanghai, China, 200025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chinese PLA General Hosp. Beijing, China, 100853 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations West China Hospital, Sichuan University Chengdu, China, 610041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A single-blind, intra-individual, crossover, multicenter study of the efficacy, safety and tolerability of Gadavist (1.0 M) in comparison with Magnevist (0.5 M) as contrast agent in the enhanced Magnetic Resonance Angiography (MRA) in Chinese patients
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Number of vessel segments visualized with diagnostic qualityTimeframe: 20-30 seconds after injection
Secondary Outcome
- Change in diagnostic confidence from pre- to post-contrast Magnetic Resonance Angiography (MRA) by investigatorTimeframe: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
- Change in diagnostic confidence from pre- to post-contrast MRA by blinded reader 1Timeframe: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
- Change in diagnostic confidence from pre- to post-contrast MRA by blinded reader 2Timeframe: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
- Change in diagnostic confidence from pre- to post-contrast MRA by blinded reader 3Timeframe: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
- MRA diagnosis by investigatorsTimeframe: 20-30 seconds after injection
- MRA diagnosis by blinded reader 1Timeframe: 20-30 seconds after injection
- MRA diagnosis by blinded reader 2Timeframe: 20-30 seconds after injection
- MRA diagnosis by blinded reader 3Timeframe: 20-30 seconds after injection
Additional Information
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