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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00681551
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : December 15, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Brain Neoplasms Drug: Magnevist (SH L 451A) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2003
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681551


Locations
Japan
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
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00681551     History of Changes
Other Study ID Numbers: 91103
305624
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: December 15, 2014
Last Verified: December 2014

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

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases