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

NCT ID: NCT00681551

Last Updated: 2014-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Neoplasms

Keywords

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Detection of brain metastasis by MRI Magnevist Brain metastasis Meglumine gadopentetate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

Magnevist (SH L 451A)

Intervention Type DRUG

Magnevist at a dose of 0.1 mmol/kg

Arm 2

Group Type EXPERIMENTAL

Magnevist (SH L 451A)

Intervention Type DRUG

Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later.

Interventions

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Magnevist (SH L 451A)

Magnevist at a dose of 0.1 mmol/kg

Intervention Type DRUG

Magnevist (SH L 451A)

Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Yokohama, Kanagawa, Japan

Site Status

Osaka, Osaka, Japan

Site Status

Osaka, Osaka, Japan

Site Status

Hamamatsu, Shizuoka, Japan

Site Status

Bunkyo-ku, Tokyo, Japan

Site Status

Ōta-ku, Tokyo, Japan

Site Status

Shinagawa-ku, Tokyo, Japan

Site Status

Shinjuku-ku, Tokyo, Japan

Site Status

Nakakoma-gun, Yamanashi, Japan

Site Status

Countries

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Japan

Other Identifiers

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305624

Identifier Type: -

Identifier Source: secondary_id

91103

Identifier Type: -

Identifier Source: org_study_id