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Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain Metastasis

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 1, 2008
Last updated: December 11, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Brain Neoplasms
Drug: Magnevist (SH L 451A)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Diagnostic ability [ Time Frame: MRI image in blinded read ]

Secondary Outcome Measures:
  • Visibility [ Time Frame: MRI image in blinded read ]
  • Diagnostic confidence [ Time Frame: MRI image in blinded read ]

Enrollment: 45
Study Start Date: February 2003
Study Completion Date: March 2004
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: Magnevist (SH L 451A)
Magnevist at a dose of 0.1 mmol/kg
Experimental: Arm 2 Drug: Magnevist (SH L 451A)
Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who are confirmed to have 1-5 metastatic brain tumor by the latest contrast-enhanced cerebral CT or contrast-enhanced cerebral MRI, and the lesion(s) have not been treated by surgery or by stereotactic radiosurgery.

Exclusion Criteria:

  • Patients who are scheduled to receive another contrast medium for MRI (except for oral agents) or iodine contrast medium (except for oral agents), or to undergo surgical procedures during the period from the day before administration of Magnevist (SH L 451A) to examination of safety on the following day.
  • Patients who underwent or are scheduled to undergo radiotherapy during the period from 14 days before administration of Magnevist (SH L 451A) to examination of safety on the following day.
  • Patients who were treated or are scheduled to be treated with anti-cancer agents (except for treatment only by the oral agents of the fixed dose continuously from 28 days or more before administration of Magnevist (SH L 451A)) during the period from 28 days before administration of Magnevist (SH L 451A) to examination of safety on the following day.
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Please refer to this study by its identifier: NCT00681551

Yokohama-shi, Kanagawa, Japan, 222-0036
Osaka-shi, Osaka, Japan, 530-8480
Osaka-shi, Osaka, Japan, 537-8511
Hamamatsu-shi, Shizuoka, Japan, 430-8558
Bunkyo-ku, Tokyo, Japan, 113-8677
Ota-ku, Tokyo, Japan, 145-0065
Shinagawa-ku, Tokyo, Japan, 141-8625
Shinjuku-ku, Tokyo, Japan, 162-8666
Nakakoma-gun, Yamanashi, Japan, 409-3898
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00681551     History of Changes
Other Study ID Numbers: 91103
Study First Received: April 1, 2008
Last Updated: December 11, 2014

Keywords provided by Bayer:
Detection of brain metastasis by MRI
Brain metastasis
Meglumine gadopentetate

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on April 26, 2017