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

NCT00681551 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2014-12-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Completion
2004-03-31

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00681551 on ClinicalTrials.gov