Study Completed

Brain Neoplasms

Bayer Identifier:

91103

ClinicalTrials.gov Identifier:

NCT00681551

EudraCT Number:

Not Available

EU CT Number:

Not Available

Magnevist (SH L 451A) intra-individual dose comparison study in patients with brain metastasis

Trial 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.

Key Participants Requirements

Sex

Both

Age

20 Years

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.

Trial summary

Enrollment Goal

Trial Dates

February 2003 - March 2004

Phase

Phase 3

Could I Receive a placebo

Products

Magnevist (Gadopentetate Dimeglumine, BAY86-4882)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	NTT Higashi Nihon Kanto Byoin	Shinagawa-ku, 141-8625, Japan
Completed	Yamanashi Daigaku Igakubu Fuzoku Byoin	Nakakoma-gun, 409-3898, Japan
Completed	Osaka Furitsu Seijinbyo Senta	Osaka-shi, 537-8511, Japan
Completed	Tokyo Toritsu Ebara Byoin	Ota-ku, 145-0065, Japan
Completed	Zaidanhojin Tazuke Kofukai Igaku Kenkyusho Kitano Byoin	Osaka-shi, 530-8480, Japan
Completed	Tokyo Joshi Ikadaigaku Byoin	Shinjuku-ku, 162-8666, Japan
Completed	Tokyo Toritsu Komagome Byoin	Bunkyo-ku, 113-8677, Japan
Completed	Yokohama Rosai Byoin	Yokohama-shi, 222-0036, Japan
Completed	Seirei Hamamatsu Byoin	Hamamatsu-shi, 430-8558, Japan

Primary Outcome

Diagnostic ability
Time Frame:
MRI image in blinded read
Safety Issue:
no

Secondary Outcome

Visibility
Time Frame:
MRI image in blinded read
Safety Issue:
no
Diagnostic confidence
Time Frame:
MRI image in blinded read
Safety Issue:
no

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Diagnostic

Allocation

Randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

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