NCT00681551

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Neoplasms

Interventions

Type	Name	Description
DRUG	Magnevist (SH L 451A)	Magnevist at a dose of 0.1 mmol/kg
DRUG	Magnevist (SH L 451A)	Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later.

Timeline

• Start date: 2003-02-01
• Completion: 2004-03-01
• First posted: 2008-05-21
• Last updated: 2014-12-15

Locations

9 sites across 1 country: Japan