Trial Condition(s):

Brain Metastases

SH L 562BB Phase II/III dose justification and gadoteridol-controlled comparative study

Bayer Identifier:

91569

ClinicalTrials.gov Identifier:

NCT00522951

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
165
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Sapporo, Japan, 060-8570

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8431

Status
Completed
 
Locations

Investigative Site

Shinagawa-ku, Japan, 141-0022

Status
Completed
 
Locations

Investigative Site

Yokohama, Japan, 222-0036

Status
Completed
 
Locations

Investigative Site

Sagamihara, Japan, 228-8555

Status
Completed
 
Locations

Investigative Site

Hamamatsu, Japan, 430-8558

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 464-0021

Status
Completed
 
Locations

Investigative Site

Yonago, Japan, 683-8504

Status
Completed
 
Locations

Investigative Site

Matsuyama, Japan, 791-0280

Status
Completed
 
Locations

Investigative Site

Kitakyushu, Japan, 807-8555

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 812-8582

Status
Completed
 
Locations

Investigative Site

Habikino, Japan, 583-8588

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 558-8558

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 650-0047

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8655

Status
Completed
 
Locations

Investigative Site

Chuo-ku, Japan, 104-0045

Status
Completed
 
Locations

Investigative Site

Mitaka, Japan, 181-8611

Status
Completed
 
Locations

Investigative Site

Sunto, Japan, 411-8777

Status
Completed
 
Locations

Investigative Site

Habikino, Japan, 583-0852

Status
Completed
 
Locations

Investigative Site

Osakasayama, Japan, 589-8511

Status
Completed
 

Trial Design