Overview

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