Magnevist (SH L 451A) Intra-Individual Dose Comparison Study in Patients With Brain Metastasis - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00681551

Purpose

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 III

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Gadolinium DTPA

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Bayer:

Primary Outcome Measures:

Diagnostic ability [ Time Frame: MRI image in blinded read ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visibility [ Time Frame: MRI image in blinded read ] [ Designated as safety issue: No ]
Diagnostic confidence [ Time Frame: MRI image in blinded read ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	December 2002
Study Completion Date:	March 2004

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: Magnevist (SH L 451A) Magnevist at a dose of 0.1 mmol/kg
Arm 2: Experimental	Drug: Magnevist (SH L 451A) Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681551

Locations

Japan, Kanagawa

Yokohama-shi, Kanagawa, Japan, 222-0036
Japan, Osaka

Osaka-shi, Osaka, Japan, 537-8511

Osaka-shi, Osaka, Japan, 530-8480
Japan, Shizuoka

Hamamatsu-shi, Shizuoka, Japan, 430-8558
Japan, Tokyo

Shinagawa-ku, Tokyo, Japan, 141-8625

Shinjuku-ku, Tokyo, Japan, 162-8666

Bunkyo-ku, Tokyo, Japan, 113-8677

Ota-ku, Tokyo, Japan, 145-0065
Japan, Yamanashi

Nakakoma-gun, Yamanashi, Japan, 409-3898

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 Schering Pharma AG )
Study ID Numbers:	91103, 305624
Study First Received:	April 1, 2008
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00681551 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:

Detection of brain metastasis by MRI
Magnevist
Brain metastasis
Meglumine gadopentetate

Study placed in the following topic categories:

Brain Neoplasms
Neoplasm Metastasis
Central Nervous System Diseases

Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases

Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009