A Randomized, Open, Parallel, Optimal Injection Rate-Finding Study for E7337 in Dynamic CT of the Liver in Patients With Liver Disease

Phase 2

Completed

• Conditions: Lesion

• Registration Number: NCT00165620
• Lead Sponsor: Eisai Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-28
• Last Update Posted: 2010-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety
Warming sensation and vascular pain
Efficacy
Contrast enhancement effect in the early arterial phase

Secondary Outcome Measures

Name	Time	Method
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