Status:
COMPLETED
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain Metastasis
Lead Sponsor:
Bayer
Conditions:
Brain Neoplasms
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00681551
Start Date
February 1 2003
End Date
March 1 2004
Last Update
December 15 2014
Active Locations (9)
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1
Yokohama, Kanagawa, Japan, 222-0036
2
Osaka, Osaka, Japan, 530-8480
3
Osaka, Osaka, Japan, 537-8511
4
Hamamatsu, Shizuoka, Japan, 430-8558