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

Brain Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681551
• Other study ID #: 91103
• Secondary ID: 305624
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2008
• Last updated: December 11, 2014
• Start date: February 2003
• Est. completion date: March 2004

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

Drug:
• Magnevist (SH L 451A)
Magnevist at a dose of 0.1 mmol/kg
• Magnevist (SH L 451A)
Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic ability		MRI image in blinded read	No
Secondary	Visibility		MRI image in blinded read	No
Secondary	Diagnostic confidence		MRI image in blinded read	No

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