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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00681551

Enrollment

Registered

2008-05-21

Start date

2003-02-28

Completion date

2004-03-31

Last updated

2014-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasms

Keywords

Detection of brain metastasis by MRI, Magnevist, Brain metastasis, Meglumine gadopentetate

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.

Interventions

DRUGMagnevist (SH L 451A)

Magnevist at a dose of 0.1 mmol/kg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Diagnostic ability	MRI image in blinded read

Secondary

Measure	Time frame
Visibility	MRI image in blinded read
Diagnostic confidence	MRI image in blinded read

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026