SH L 562BB Phase II/III Dose Justification and Gadoteridol-Controlled Comparative Study - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00522951

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.

Condition	Intervention	Phase
Brain Metastases	Drug: Gadovist (Gadobutrol) Drug: ProHance	Phase III

Drug Information available for: Gadoteridol Gadobutrol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Subject), Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Official Title:	Multi-Center, Randomized, Controlled, Single-Blind, Intra-Individual Comparisons of 2 Dose of Gadobutrol 1.0 Molar and Gadoteridol (ProHance) Crossover Studies With Corresponding Blinded Image Evaluation Following Multiple Injections of 0.1 Mmol/kg bw of Gadobutrol and Gadoteridol in Patients With Known or Suspected Brain Metastasis

Further study details as provided by Bayer:

Primary Outcome Measures:

The total number of metastatic lesions detected. [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Confidence and performance in treatment planning, [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
Visibility of lesions, [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
Contrast noise ratio by signal intensity and size measurement. [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Enrollment:	164
Study Start Date:	August 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Gadovist (Gadobutrol) Gadobutrol enhanced MRI (first injection, corresponding to a dose of 0.1 mmol/kg bw)
Arm 2: Experimental	Drug: ProHance Gadobutrol enhanced MRI (second injection, corresponding to a total dose of 0.2 mmol/kg bw)
Arm 3: Experimental	Drug: Gadovist (Gadobutrol) ProHance enhanced MRI (additional injection, corresponding to a total dose of 0.2 mmol/kg bw)

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522951

Locations

Japan

Fukuoka, Japan, 812-8582

Osaka, Japan, 558-8558
Japan, Aichi

Nagoya, Aichi, Japan, 464-0021
Japan, Ehime

Matsuyama, Ehime, Japan, 791-0280
Japan, Fukuoka

Kitakyushu, Fukuoka, Japan, 807-8555
Japan, Hokkaido

Sapporo, Hokkaido, Japan, 060-8570
Japan, Hyogo

Kobe, Hyogo, Japan, 650-0047
Japan, Kanagawa

Yokohama, Kanagawa, Japan, 222-0036

Sagamihara, Kanagawa, Japan, 228-0829
Japan, Osaka

Habikino, Osaka, Japan, 583-0852

Habikino, Osaka, Japan, 583-8588

Osakasayama, Osaka, Japan, 589-8511
Japan, Shizuoka

Sunto, Shizuoka, Japan, 411-8777

Hamamatsu, Shizuoka, Japan, 430-0906
Japan, Tokyo

Bunkyo-ku, Tokyo, Japan, 113-8431

Bunkyo-ku, Tokyo, Japan, 113-8655

Chuo-ku, Tokyo, Japan, 104-0045

Shinagawa-ku, Tokyo, Japan, 141-0022

Mitaka, Tokyo, Japan, 181-0004
Japan, Tottori

Yonago, Tottori, Japan, 683-8504

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

Responsible Party:	Bayer Yakuhin Ltd. ( Therapeutic Area Head )
Study ID Numbers:	91569, 310864
Study First Received:	August 29, 2007
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00522951
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:

MRI
Brain Metastasis
Gadolinium
Imaging
Diagnostic Agent

Study placed in the following topic categories:

Brain Neoplasms
Neoplasm Metastasis
Central Nervous System Diseases

Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009