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

NCT00681551 Phase 3 COMPLETED

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.

Details

Lead sponsor	Bayer
Phase	Phase 3
Status	COMPLETED
Enrolment	45
Start date	2003-02
Completion	2004-03

Conditions

• Brain Neoplasms

Interventions

• Magnevist (SH L 451A)
• Magnevist (SH L 451A)

Primary outcomes

• Diagnostic ability — MRI image in blinded read

Countries

Japan