Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients - Full Text View

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.

Condition	Intervention	Phase
Vascular Diseases	Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans Vascular Diseases

Drug Information available for: Gadopentetate dimeglumine Gadobenate Dimeglumine Gadobutrol

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Number of Vessel Segments Visualized With Diagnostic Quality [ Time Frame: 20-30 seconds after injection ] [ Designated as safety issue: No ]
Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image.

Secondary Outcome Measures:

Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator [ Time Frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast) ] [ Designated as safety issue: No ]
The on-site investigators assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 [ Time Frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast) ] [ Designated as safety issue: No ]
Independent blinded reader 1 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 [ Time Frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast) ] [ Designated as safety issue: No ]
Independent blinded reader 2 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 [ Time Frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast) ] [ Designated as safety issue: No ]
Independent blinded reader 3 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
MRA Diagnosis by Investigators [ Time Frame: 20-30 seconds after injection ] [ Designated as safety issue: No ]
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
MRA Diagnosis by Blinded Reader 1 [ Time Frame: 20-30 seconds after injection ] [ Designated as safety issue: No ]
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
MRA Diagnosis by Blinded Reader 2 [ Time Frame: 20-30 seconds after injection ] [ Designated as safety issue: No ]
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
MRA Diagnosis by Blinded Reader 3 [ Time Frame: 20-30 seconds after injection ] [ Designated as safety issue: No ]
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.

Enrollment:	83
Study Start Date:	October 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Gadobutrol, then Gadopentate dimeglumine Period 1: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged; Period 2: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged	Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW) Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882) Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
Experimental: Gadopentate, dimeglumine then Gadobutrol Period 1: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged; Period 2: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged	Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW) Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882) Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)

Arms

Assigned Interventions

Experimental: Gadobutrol, then Gadopentate dimeglumine

Period 1: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged; Period 2: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged

Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)

Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)

Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)

Experimental: Gadopentate, dimeglumine then Gadobutrol

Period 1: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged; Period 2: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged

Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)

Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)

Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395733

Locations

China, Sichuan

Chengdu, Sichuan, China, 610041
China

Beijing, China, 100853

Shanghai, China, 200025

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT00395733 History of Changes
Other Study ID Numbers:	91537, 309762
Study First Received:	November 2, 2006
Results First Received:	July 5, 2011
Last Updated:	November 23, 2012
Health Authority:	China: Food and Drug Administration

Keywords provided by Bayer:

Gadovist
Gadavist
MRI Imaging
vascular diseases
Chinese

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013