Intra-individual Comparison Study of Intravenously Administered Magnevist (SH L 451A) on Lesion Detection Ability in MRI After an Initial Dose of 0.1 mmol/kg and After an Additional Dose of 0.1 mmol/kg in Patients With Metastatic Brain Tumor
Sponsor study identifier
Secondary identifiers
interventional
45
1 country
9
Study Start
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
March 2004
Actual (reported)To verify the number of metastatic brain tumors detected in contrast-enhanced MRI, which is the primary variable, increases after an additional dose of Magnevist (SH L 451A) comparing images after an initial dose (0.1 mmol/kg) with those after an additional dose (0.1 mmol/kg, a total dose of 0.2 mmol/kg) intra-individually in patients with metastatic brain tumors. Safety was also to be assessed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2004
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
March 2004
Actual (reported)April 1, 2008
Actual (reported)May 21, 2008
Actual (reported)Diagnostic ability
MRI image in blinded read
Visibility
MRI image in blinded read
Diagnostic confidence
MRI image in blinded read
Magnevist at a dose of 0.1 mmol/kg
Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Yokohama, Kanagawa, 222-0036, Japan
Osaka, Osaka, 530-8480, Japan
Osaka, Osaka, 537-8511, Japan
Hamamatsu, Shizuoka, 430-8558, Japan
Bunkyo-ku, Tokyo, 113-8677, Japan
Ōta-ku, Tokyo, 145-0065, Japan
Shinagawa-ku, Tokyo, 141-8625, Japan
Bayer Study Director
Bayer
45 participants (actual enrollment reported by the registry).
First Submitted
April 1, 2008
First Posted
May 21, 2008
Study Start
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
A Trial Comparing Radiosurgery With Surgery for Solitary Brain Metastases
Contact the study team to confirm eligibility.
Shinjuku-ku, Tokyo, 162-8666, Japan
Nakakoma-gun, Yamanashi, 409-3898, Japan
Study Completion
March 2004
Actual (reported)Last Updated
December 15, 2014
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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