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

April 1, 2008
October 10, 2013
December 2002
Not Provided
Diagnostic ability [ Time Frame: MRI image in blinded read ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00681551 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain Metastasis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Brain Neoplasms
  • Drug: Magnevist (SH L 451A)
    Magnevist at a dose of 0.1 mmol/kg
  • Drug: Magnevist (SH L 451A)
    Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later.
  • Active Comparator: Arm 1
    Intervention: Drug: Magnevist (SH L 451A)
  • Experimental: Arm 2
    Intervention: Drug: Magnevist (SH L 451A)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
March 2004
Not Provided

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00681551
91103, 305624
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP