Clinical trial NCT00395460: Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Central Nervous System Diseases
Keywords: Gadovist
Gadavist
Contrast agent
Brain
Spine disease
Magnetic Resonance Imaging
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-11-03
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions
timeFrame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Secondary outcomes:
measure: Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan
timeFrame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
measure: Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment
timeFrame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
measure: Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI
timeFrame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
measure: Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions
timeFrame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Other outcomes:
measure: Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases
timeFrame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
measure: Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases
timeFrame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
measure: Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases
timeFrame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
measure: Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases
timeFrame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Xi'an
country: China
facility: The 1st Affiliated Hosp of the 4th Military Med Uni
state: Shaanxi
city: Beijing
country: China
facility: Chinese PLA General Hosp.
city: Shanghai
country: China
facility: Fudan University Huashan Hospital
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Liang Z; Ma L; Wang D; Huan Y; Li P; Yu J; Yao Z; Chen S; He H; Feng X and Breuer J. Efficacy and Safety of Gadobutrol (1.0 M) versus Gadopentetate Dimeglumine (0.5 M) for Enhanced MRI of CNS Lesions: A Phase III, Multicenter, SingleBlind, Randomized Study in Chinese Patients. Magnetic Resonance Insights 2012; 5:17-28