SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

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