Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients

Central Nervous System Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395460
• Other study ID #: 91536
• Secondary ID: Project DE 00562
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2006
• Last updated: May 13, 2015
• Start date: September 2006
• Est. completion date: April 2007

Study information

• Verified date: May 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Nervous System Diseases

Intervention

Drug:
• Gadobutrol (Gadavist, Gadovist, BAY86-4875)
1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW)
• Magnevist
0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)

Locations

Country	Name	City	State
China	Chinese PLA General Hosp.	Beijing
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Fudan University Huashan Hospital	Shanghai
China	The 1st Affiliated Hosp of the 4th Military Med Uni	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

References & Publications (1)

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 Stud

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	CNR = (SI lesion - SI normal tissue) / 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.	Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)	No
Other	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	CNR = (SI lesion - SI normal tissue) / 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.	Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)	No
Other	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	Investigators and blinded readers (reader 2, 3 and 4) were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.	Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)	No
Other	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	Investigators and blinded readers (reader 2, 3 and 4= were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.	Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)	No
Primary	Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions	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.	Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)	No
Secondary	Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan	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).	Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)	No
Secondary	Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment	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).	Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)	No
Secondary	Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI	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).	Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)	No
Secondary	Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions	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).	Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)	No

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