Trial Condition(s):

Brain Neoplasms

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

Bayer Identifier:

91103

ClinicalTrials.gov Identifier:

NCT00681551

EudraCT Number:

Not Available

Study Completed

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.

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
45
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

NTT Higashi Nihon Kanto Byoin

Shinagawa-ku, Japan, 141-8625

Status
Completed
 
Locations

Yamanashi Daigaku Igakubu Fuzoku Byoin

Nakakoma-gun, Japan, 409-3898

Status
Completed
 
Locations

Osaka Furitsu Seijinbyo Senta

Osaka-shi, Japan, 537-8511

Status
Completed
 
Locations

Tokyo Toritsu Ebara Byoin

Ota-ku, Japan, 145-0065

Status
Completed
 
Locations

Zaidanhojin Tazuke Kofukai Igaku Kenkyusho Kitano Byoin

Osaka-shi, Japan, 530-8480

Status
Completed
 
Locations

Tokyo Joshi Ikadaigaku Byoin

Shinjuku-ku, Japan, 162-8666

Status
Completed
 
Locations

Tokyo Toritsu Komagome Byoin

Bunkyo-ku, Japan, 113-8677

Status
Completed
 
Locations

Yokohama Rosai Byoin

Yokohama-shi, Japan, 222-0036

Status
Completed
 
Locations

Seirei Hamamatsu Byoin

Hamamatsu-shi, Japan, 430-8558

Status
Completed
 

Trial Design