SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
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
2 other identifiers
interventional
165
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2007
Shorter than P25 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 29, 2007
CompletedFirst Posted
Study publicly available on registry
August 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
August 3, 2011
CompletedAugust 28, 2017
July 1, 2017
1 year
August 29, 2007
July 5, 2011
July 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Lesions Detected by Blinded Readers (BR) and Investigator
Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator
one day
Secondary Outcomes (15)
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader
one day
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator
one day
Score of Visibility Assessment - Border Delineation by Blinded Reader
one day
Score of Visibility Assessment - Border Delineation by Investigator
one day
Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)
one day
- +10 more secondary outcomes
Study Arms (3)
Gadobutrol 0.1 mmol/kg bw
EXPERIMENTALParticipants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
Gadobutrol 0.2 mmol/kg bw
EXPERIMENTALParticipants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Gadoteridol (ProHance)
EXPERIMENTALParticipants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Interventions
Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw)
ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)
Eligibility Criteria
You may qualify if:
- Japanese patients at least 20 years of age
- Patients with diagnosed primary cancer
- Patients with metastatic lesions by CT/MRI
You may not qualify if:
- Patients who have contraindication to the MRI examinations
- Patients who have severe renal disorder
- Patients in extremely serious general condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (20)
Unknown Facility
Nagoya, Aichi-ken, 464-0021, Japan
Unknown Facility
Matsuyama, Ehime, 791-0280, Japan
Unknown Facility
Kitakyushu, Fukuoka, 807-8555, Japan
Unknown Facility
Sapporo, Hokkaido, 060-8570, Japan
Unknown Facility
Kobe, Hyōgo, 650-0047, Japan
Unknown Facility
Sagamihara, Kanagawa, 228-8555, Japan
Unknown Facility
Yokohama, Kanagawa, 222-0036, Japan
Unknown Facility
Habikino, Osaka, 583-0852, Japan
Unknown Facility
Habikino, Osaka, 583-8588, Japan
Unknown Facility
Sayama, Osaka, 589-8511, Japan
Unknown Facility
Hamamatsu, Shizuoka, 430-8558, Japan
Unknown Facility
Sunto, Shizuoka, 411-8777, Japan
Unknown Facility
Bunkyo-ku, Tokyo, 113-8431, Japan
Unknown Facility
Bunkyo-ku, Tokyo, 113-8655, Japan
Unknown Facility
Chuo-ku, Tokyo, 104-0045, Japan
Unknown Facility
Mitaka, Tokyo, 181-8611, Japan
Unknown Facility
Shinagawa-ku, Tokyo, 141-0022, Japan
Unknown Facility
Yonago, Tottori, 683-8504, Japan
Unknown Facility
Fukuoka, 812-8582, Japan
Unknown Facility
Osaka, 558-8558, Japan
Related Publications (1)
Katakami N, Inaba Y, Sugata S, Tsurusaki M, Itoh T, Machida T, Tanaka H, Nakayama T, Morikawa T, Breuer J, Aitoku Y. Magnetic resonance evaluation of brain metastases from systemic malignances with two doses of gadobutrol 1.0 m compared with gadoteridol: a multicenter, phase ii/iii study in patients with known or suspected brain metastases. Invest Radiol. 2011 Jul;46(7):411-8. doi: 10.1097/RLI.0b013e3182145a6c.
PMID: 21467949RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2007
First Posted
August 30, 2007
Study Start
August 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
August 28, 2017
Results First Posted
August 3, 2011
Record last verified: 2017-07