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

Phase 3

Completed

• Conditions: Brain Neoplasms
• Interventions: Drug: Magnevist (SH L 451A)

• Registration Number: NCT00681551
• Lead Sponsor: Bayer

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 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

Not available

Study Timeline

• Study Start: 2003-02
• Study Completion: 2004-03
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Magnevist (SH L 451A)	-
Arm 2	Magnevist (SH L 451A)	-

Primary Outcome Measures

Name	Time	Method
Diagnostic ability	MRI image in blinded read

Secondary Outcome Measures

Name	Time	Method
Visibility	MRI image in blinded read
Diagnostic confidence	MRI image in blinded read