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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Brain Neoplasms

Intervention / Treatment
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* Drug: Magnevist (SH L 451A)
* Drug: Magnevist (SH L 451A)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: Magnevist (SH L 451A)<br>* Magnevist at a dose of 0.1 mmol/kg<br>|
| Experimental: Arm 2<br> | Drug: Magnevist (SH L 451A)<br>* Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic ability |  | MRI image in blinded read | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visibility |  | MRI image in blinded read | 
| Diagnostic confidence |  | MRI image in blinded read | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Detection of brain metastasis by MRI, Magnevist, Brain metastasis, Meglumine gadopentetate