Trial Condition(s):
Brain Neoplasms
Magnevist (SH L 451A) intra-individual dose comparison study in patients with brain metastasis
Bayer Identifier:
91103
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations NTT Higashi Nihon Kanto Byoin Shinagawa-ku, Japan, 141-8625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yamanashi Daigaku Igakubu Fuzoku Byoin Nakakoma-gun, Japan, 409-3898 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka Furitsu Seijinbyo Senta Osaka-shi, Japan, 537-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokyo Toritsu Ebara Byoin Ota-ku, Japan, 145-0065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zaidanhojin Tazuke Kofukai Igaku Kenkyusho Kitano Byoin Osaka-shi, Japan, 530-8480 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokyo Joshi Ikadaigaku Byoin Shinjuku-ku, Japan, 162-8666 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokyo Toritsu Komagome Byoin Bunkyo-ku, Japan, 113-8677 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yokohama Rosai Byoin Yokohama-shi, Japan, 222-0036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seirei Hamamatsu Byoin Hamamatsu-shi, Japan, 430-8558 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Diagnostic abilityTimeframe: MRI image in blinded read
Secondary Outcome
- VisibilityTimeframe: MRI image in blinded read
- Diagnostic confidenceTimeframe: MRI image in blinded read
Additional Information
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