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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


Phase 3
20 Years
N/A
Not Enrolling
Both
Brain Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Diagnostic ability

Outcome Time Frame:

MRI image in blinded read

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

91103

NCT ID:

NCT00681551

Start Date:

December 2002

Completion Date:

March 2004

Related Keywords:

  • Brain Neoplasms
  • Detection of brain metastasis by MRI
  • Magnevist
  • Brain metastasis
  • Meglumine gadopentetate
  • Brain Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

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