check_circleStudy Completed

Brain Neoplasms

Bayer Identifier:

91103

ClinicalTrials.gov Identifier:

NCT00681551

EudraCT Number:

Not Available

EU CT Number:

Not Available
Magnevist (SH L 451A) intra-individual dose comparison study in patients with brain metastasis

Trial 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.

Key Participants Requirements

Sex

Both

Age

20 Years
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
45
Trial Dates
February 2003 - March 2004
Phase
Phase 3
Could I Receive a placebo
No
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
NTT Higashi Nihon Kanto ByoinShinagawa-ku, 141-8625, Japan
Completed
Yamanashi Daigaku Igakubu Fuzoku ByoinNakakoma-gun, 409-3898, Japan
Completed
Osaka Furitsu Seijinbyo SentaOsaka-shi, 537-8511, Japan
Completed
Tokyo Toritsu Ebara ByoinOta-ku, 145-0065, Japan
Completed
Zaidanhojin Tazuke Kofukai Igaku Kenkyusho Kitano ByoinOsaka-shi, 530-8480, Japan
Completed
Tokyo Joshi Ikadaigaku ByoinShinjuku-ku, 162-8666, Japan
Completed
Tokyo Toritsu Komagome ByoinBunkyo-ku, 113-8677, Japan
Completed
Yokohama Rosai ByoinYokohama-shi, 222-0036, Japan
Completed
Seirei Hamamatsu ByoinHamamatsu-shi, 430-8558, Japan

Primary Outcome

  • Diagnostic ability
    date_rangeTime Frame:
    MRI image in blinded read
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Visibility
    date_rangeTime Frame:
    MRI image in blinded read
    enhanced_encryption
    Safety Issue:
    no
  • Diagnostic confidence
    date_rangeTime Frame:
    MRI image in blinded read
    enhanced_encryption
    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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