NCT00681551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
Last Updated

December 15, 2014

Status Verified

December 1, 2014

First QC Date

April 1, 2008

Last Update Submit

December 11, 2014

Conditions

Brain Neoplasms

Keywords

Detection of brain metastasis by MRIMagnevistBrain metastasisMeglumine gadopentetate

Outcome Measures

Primary Outcomes (1)

  • Diagnostic ability

    MRI image in blinded read

Secondary Outcomes (2)

  • Visibility

    MRI image in blinded read

  • Diagnostic confidence

    MRI image in blinded read

Study Arms (2)

Arm 1

ACTIVE COMPARATOR
Drug: Magnevist (SH L 451A)

Arm 2

EXPERIMENTAL
Drug: Magnevist (SH L 451A)

Interventions

Magnevist (SH L 451A)DRUG

Magnevist at a dose of 0.1 mmol/kg

Arm 1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Yokohama, Kanagawa, 222-0036, Japan

Location

Unknown Facility

Osaka, Osaka, 530-8480, Japan

Location

Unknown Facility

Osaka, Osaka, 537-8511, Japan

Location

Unknown Facility

Hamamatsu, Shizuoka, 430-8558, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-8677, Japan

Location

Unknown Facility

Ōta-ku, Tokyo, 145-0065, Japan

Location

Unknown Facility

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Unknown Facility

Nakakoma-gun, Yamanashi, 409-3898, Japan

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Gadolinium DTPA

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Pentetic AcidPolyaminesAminesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsCoordination Complexes

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2008

First Posted

May 21, 2008

Study Start

February 1, 2003

Study Completion

March 1, 2004

Last Updated

December 15, 2014

Record last verified: 2014-12

Locations

JP(9)