Magnevist (SH L 451A) Intra-Individual Dose Comparison Study in Patients With Brain Metastasis
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00681551
First received: April 1, 2008
Last updated: July 6, 2009
Last verified: July 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Neoplasms |
Drug: Magnevist (SH L 451A) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Diagnostic ability [ Time Frame: MRI image in blinded read ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Visibility [ Time Frame: MRI image in blinded read ] [ Designated as safety issue: No ]
- Diagnostic confidence [ Time Frame: MRI image in blinded read ] [ Designated as safety issue: No ]
| Enrollment: | 70 |
| Study Start Date: | December 2002 |
| Study Completion Date: | March 2004 |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Arm 1 |
Drug: Magnevist (SH L 451A)
Magnevist at a dose of 0.1 mmol/kg
|
| Experimental: Arm 2 |
Drug: Magnevist (SH L 451A)
Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later.
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681551
Locations
| Japan | |
| Yokohama-shi, Kanagawa, Japan, 222-0036 | |
| Osaka-shi, Osaka, Japan, 537-8511 | |
| Osaka-shi, Osaka, Japan, 530-8480 | |
| Hamamatsu-shi, Shizuoka, Japan, 430-8558 | |
| Bunkyo-ku, Tokyo, Japan, 113-8677 | |
| Ota-ku, Tokyo, Japan, 145-0065 | |
| Shinagawa-ku, Tokyo, Japan, 141-8625 | |
| Shinjuku-ku, Tokyo, Japan, 162-8666 | |
| Nakakoma-gun, Yamanashi, Japan, 409-3898 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Schering Pharma AG |
| ClinicalTrials.gov Identifier: | NCT00681551 History of Changes |
| Other Study ID Numbers: | 91103, 305624 |
| Study First Received: | April 1, 2008 |
| Last Updated: | July 6, 2009 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Bayer:
|
Detection of brain metastasis by MRI Magnevist Brain metastasis Meglumine gadopentetate |
Additional relevant MeSH terms:
|
Brain Neoplasms Neoplasms Neoplasm Metastasis Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013