To establish the optimum injection rate for E7337 (Iomeron 350) in dynamic CT in patients who have hepatic lesions.The primary endpoint for efficacy is the contrast enhancement effect in the early arterial phase, and the primary safety endpoints are warming sensation and vascular pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Unnamed facility
Kumamoto, Kumamoto, Japan
Unnamed facility
Suita, Osaka, Japan
Efficacy
Contrast enhancement effect in the early arterial phase
Safety
Warming sensation and vascular pain
Efficacy
Contrast enhancement effect in the portal phase
Safety and arterial, portal venous and liver parenchymal CT values (HU)
Symptoms and signs(excluding warming sensation and vascular pain ), and life signs (blood pressure, pulse), etc., and laboratory tests (hematology, serum chemistry) conducted before and after administration of the investigational agent
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