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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00395460
First received: November 2, 2006
Last updated: October 11, 2013
Last verified: October 2013
  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.


Condition Intervention Phase
Central Nervous System Diseases
Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Drug: Magnevist
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions [ Time Frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) ] [ Designated as safety issue: No ]
    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:
  • Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan [ Time Frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) ] [ Designated as safety issue: No ]
    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 Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment [ Time Frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) ] [ Designated as safety issue: No ]
    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 Lesion Contrast Enhancement From Pre- to Post-contrast MRI [ Time Frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) ] [ Designated as safety issue: No ]
    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).


Other Outcome Measures:
  • 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 [ Time Frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast) ] [ Designated as safety issue: No ]
    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.


Enrollment: 147
Study Start Date: September 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, 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)
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)
Active Comparator: GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)
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
Drug: Magnevist
0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395460

Locations
China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
China, Shaanxi
The 1st Affiliated Hosp of the 4th Military Med Uni
Xi'an, Shaanxi, China, 710032
China
Chinese PLA General Hosp.
Beijing, China, 100853
Fudan University Huashan Hospital
Shanghai, China, 200040
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00395460     History of Changes
Other Study ID Numbers: 91536, Project DE 00562, 309761
Study First Received: November 2, 2006
Results First Received: July 4, 2011
Last Updated: October 11, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Bayer:
Gadovist
Gadavist
Contrast agent
Brain
Spine disease
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Nervous System Diseases
Central Nervous System Diseases
Contrast Media
Gadobutrol
Gadolinium DTPA
Gadobenic acid
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014