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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00681551
First received: April 1, 2008
Last updated: October 10, 2013
Last verified: October 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681551

Locations
Japan
Yokohama-shi, Kanagawa, Japan, 222-0036
Osaka-shi, Osaka, Japan, 530-8480
Osaka-shi, Osaka, Japan, 537-8511
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: Bayer
ClinicalTrials.gov Identifier: NCT00681551     History of Changes
Other Study ID Numbers: 91103, 305624
Study First Received: April 1, 2008
Last Updated: October 10, 2013
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
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Gadolinium DTPA
Gadobenic acid
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014