Back to resultsMagnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain Metastasis
Primary Purpose
Brain Neoplasms
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Magnevist (SH L 451A)
Magnevist (SH L 451A)
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Neoplasms focused on measuring Detection of brain metastasis by MRI, Magnevist, Brain metastasis, Meglumine gadopentetate
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Diagnostic ability
Secondary Outcome Measures
Visibility
Diagnostic confidence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00681551
Brief Title
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain Metastasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms
Keywords
Detection of brain metastasis by MRI, Magnevist, Brain metastasis, Meglumine gadopentetate
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Magnevist (SH L 451A)
Intervention Description
Magnevist at a dose of 0.1 mmol/kg
Intervention Type
Drug
Intervention Name(s)
Magnevist (SH L 451A)
Intervention Description
Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later.
Primary Outcome Measure Information:
Title
Diagnostic ability
Time Frame
MRI image in blinded read
Secondary Outcome Measure Information:
Title
Visibility
Time Frame
MRI image in blinded read
Title
Diagnostic confidence
Time Frame
MRI image in blinded read
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
530-8480
Country
Japan
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
537-8511
Country
Japan
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
430-8558
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
145-0065
Country
Japan
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
City
Nakakoma-gun
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain Metastasis
We'll reach out to this number within 24 hrs