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

PHASE3CompletedINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

August 31, 2008

Study Completion Date

August 31, 2008

Conditions
Brain Metastases
Interventions
DRUG

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw)

DRUG

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Gadobutrol enhanced MRI (second injection of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)

DRUG

ProHance

ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)

Trial Locations (20)

464-0021

Nagoya

791-0280

Matsuyama

807-8555

Kitakyushu

060-8570

Sapporo

650-0047

Kobe

228-8555

Sagamihara

222-0036

Yokohama

583-0852

Habikino

583-8588

Habikino

589-8511

Sayama

430-8558

Hamamatsu

411-8777

Sunto

113-8431

Bunkyo-ku

113-8655

Bunkyo-ku

104-0045

Chuo-ku

181-8611

Mitaka

141-0022

Shinagawa-ku

683-8504

Yonago

812-8582

Fukuoka

558-8558

Osaka

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY