Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
- Conditions
- Central Nervous System Diseases
- Interventions
- Registration Number
- NCT00395460
- Lead Sponsor
- Bayer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875) Gadobutrol (Gadavist, Gadovist, BAY86-4875) Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec) GD 0.1 mmol/kg BW (Magnevist, BAY86-4882) Magnevist Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
- Primary Outcome Measures
Name Time Method Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) CNR = (signal intensity \[SI\] lesion - SI normal tissue) / standard deviation (SD) background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.
- Secondary Outcome Measures
Name Time Method Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) The change in diagnostic confidence was assessed based on post-contrast compared to pre-contrast scans as "improved", "unchanged" or "worsened" for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).
Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) The number of lesions in the magnetic resonance scans was recorded before and after injection of contrast agent for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).
Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) The degree of contrast enhancement was recorded on a 4-point scale as follows: 1 = No: lesion is not enhanced. 2 = Moderate: lesion is weakly enhanced. 3 = Good: lesion is clearly enhanced. 4 = Excellent: lesion is clearly and brightly enhanced. In case of more than one lesion, the lesion with maximum enhancement was to be assessed. The change in lesion contrast enhancement was assessed based on post-contrast in comparison to pre-contrast scans for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).
Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) Lesion delineation was recorded on a 4-point scale as follows: 1 = None: no or unclear delineation of the boundary between lesion and surrounding tissue; 2 = Moderate: some aspects of border delineation covered; 3 = Good: almost clear delineation, but not complete on relevant slices; 4 = Excellent: sharp and complete delineation. In case of more than one lesion, the lesion with maximum enhancement was assessed. Change in lesion delineation was assessed based on post-contrast in comparison to pre-contrast scans for investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).
Trial Locations
- Locations (4)
Fudan University Huashan Hospital
🇨🇳Shanghai, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The 1st Affiliated Hosp of the 4th Military Med Uni
🇨🇳Xi'an, Shaanxi, China
Chinese PLA General Hosp.
🇨🇳Beijing, China