Multi-center, Randomized, Controlled, Single-blind, Intra-individual Comparisons of 2 Dose of Gadobutrol 1.0 Molar and Gadoteridol (ProHance) Crossover Studies With Corresponding Blinded Image Evaluation Following Multiple Injections of 0.1 mmol/kg bw of Gadobutrol and Gadoteridol in Patients With Known or Suspected Brain Metastasis
20 Years
N/A
Both
Brain Metastases
Trial Information
Multi-center, Randomized, Controlled, Single-blind, Intra-individual Comparisons of 2 Dose of Gadobutrol 1.0 Molar and Gadoteridol (ProHance) Crossover Studies With Corresponding Blinded Image Evaluation Following Multiple Injections of 0.1 mmol/kg bw of Gadobutrol and Gadoteridol in Patients With Known or Suspected Brain Metastasis
Inclusion Criteria:
- Japanese patients at least 20 years of age
- Patients with diagnosed primary cancer
- Patients with metastatic lesions by CT/MRI
Exclusion Criteria:
- Patients who have contraindication to the MRI examinations
- Patients who have severe renal disorder
- Patients in extremely serious general condition
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Outcome Measure:
Number of Lesions Detected by Blinded Readers (BR) and Investigator
Outcome Description:
Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator
Outcome Time Frame:
one day
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
91569
NCT ID:
NCT00522951
Start Date:
August 2007
Completion Date:
August 2008
Related Keywords:
- Brain Metastases
- MRI
- Brain Metastasis
- Gadolinium
- Imaging
- Diagnostic Agent
- Neoplasm Metastasis
- Brain Neoplasms
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