check_circleStudy Completed
Brain Neoplasms
Bayer Identifier:
91103
ClinicalTrials.gov Identifier:
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
BothAge
20 YearsTrial summary
Enrollment Goal
45Trial Dates
February 2003 - March 2004Phase
Phase 3Could I Receive a placebo
NoProducts
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | NTT Higashi Nihon Kanto Byoin | Shinagawa-ku, 141-8625, Japan |
Completed | Yamanashi Daigaku Igakubu Fuzoku Byoin | Nakakoma-gun, 409-3898, Japan |
Completed | Osaka Furitsu Seijinbyo Senta | Osaka-shi, 537-8511, Japan |
Completed | Tokyo Toritsu Ebara Byoin | Ota-ku, 145-0065, Japan |
Completed | Zaidanhojin Tazuke Kofukai Igaku Kenkyusho Kitano Byoin | Osaka-shi, 530-8480, Japan |
Completed | Tokyo Joshi Ikadaigaku Byoin | Shinjuku-ku, 162-8666, Japan |
Completed | Tokyo Toritsu Komagome Byoin | Bunkyo-ku, 113-8677, Japan |
Completed | Yokohama Rosai Byoin | Yokohama-shi, 222-0036, Japan |
Completed | Seirei Hamamatsu Byoin | Hamamatsu-shi, 430-8558, Japan |
Primary Outcome
- Diagnostic abilitydate_rangeTime Frame:MRI image in blinded readenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Visibilitydate_rangeTime Frame:MRI image in blinded readenhanced_encryptionnoSafety Issue:
- Diagnostic confidencedate_rangeTime Frame:MRI image in blinded readenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2