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Trial registered on ANZCTR


Registration number
ACTRN12608000455369
Ethics application status
Approved
Date submitted
13/08/2008
Date registered
15/09/2008
Date last updated
13/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical study to determine the safety and efficacy of gadobutrol 1.0 molar (Gadovist 'Registered trade mark') in comparison to ProHance 'Registered trade mark' (gadoteridol) 0.5 molar in patients referred for contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system.
Scientific title
A multicenter, randomized, double-blind, crossover, phase 3 study to determine the safety and efficacy of gadobutrol 1.0 molar (Gadovist 'Registered trade mark') in patients referred for contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system (CNS). Protocol number 310123
Secondary ID [1] 681 0
ClinicalTrials.gov identifier: NCT00709852
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central nervous system diseases requiring a contrast-enhanced MRI of the CNS. 3554 0
Condition category
Condition code
Neurological 3711 3711 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug: Gadovist 'Registered trade mark' (Gadobutrol) 1.0 molar; dose 0.1 mmol/kg; route of administration intravenous; duration of treatment is single dose;washout period 24 hours; MRI using steady state sequences.
Intervention code [1] 3266 0
Diagnosis / Prognosis
Comparator / control treatment
Drug: ProHance 'Registered trade mark' (Gadoteridol) 0.5 molar; dose 0.1 mmol/kg; route of administration intravenous; duration of treatment is single dose; MRI using steady state sequences.
Control group
Active

Outcomes
Primary outcome [1] 4613 0
To demonstrate superiority of combined unenhanced and gadobutrol-enhanced magnetic resonance imaging (MRI), based on degree of enhancement, border delineation, and internal morpholgy.
Timepoint [1] 4613 0
4 minutes post injection.
Primary outcome [2] 4714 0
To demonstrate noninferiority of combined unenhanced and gadobutrol-enhanced magnetic resonance imaging (MRI), based on number of lesions detected.
Timepoint [2] 4714 0
4 minutes post injection.
Secondary outcome [1] 7782 0
Demonstrate improvement of gadobutrol-enhanced MRI to unenhanced MRI and noninferiority to gadoteridol-enhanced MRI for: exact match of the MRI diagnoses with the final clinical diagnosis using the independent standard of truth evaluation.
Timepoint [1] 7782 0
MRI 4 minutes post injection.
Secondary outcome [2] 7961 0
To demonstrate noninferiority of gadobutrol compared to gadoteridol for: degree of contrast enhancement, border delineation, internal morphology, total number of lesions.
Timepoint [2] 7961 0
MRI 4 minutes post injection.
Secondary outcome [3] 7962 0
Assess the safety profile of gadobutrol compared to gadoteridol after intravenous (IV) administration. Based on vital signs, physical examinations, clinical laboratory parameters and monitoring of adverse events.
Timepoint [3] 7962 0
MRI 4 minutes post injection.

Eligibility
Key inclusion criteria
Is referred for a contrast-enhanced MRI of the Central Nervous System based on current clinical symptoms or results of a previous imaging procedure.
Has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and has consented to participate.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents.
Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents.
Has severe cardiovascular disease (eg, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours).
Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by an interactive voice response system (IVRS) is used to accomplish a blind allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random code.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1105 0
3168
Recruitment outside Australia
Country [1] 1154 0
United States of America
State/province [1] 1154 0
Country [2] 1155 0
Japan
State/province [2] 1155 0
Country [3] 1156 0
Germany
State/province [3] 1156 0
Country [4] 1157 0
Austria
State/province [4] 1157 0
Country [5] 1158 0
Colombia
State/province [5] 1158 0
Country [6] 1159 0
India
State/province [6] 1159 0
Country [7] 1160 0
Switzerland
State/province [7] 1160 0

Funding & Sponsors
Funding source category [1] 3734 0
Commercial sector/Industry
Name [1] 3734 0
Bayer Australia Ltd
Address [1] 3734 0
875 Pacific Highway
Pymble, NSW 2073
Country [1] 3734 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bayer Australia Ltd
Address
875 Pacific Highway
Pymble, NSW 2073
Country
Australia
Secondary sponsor category [1] 3475 0
None
Name [1] 3475 0
Address [1] 3475 0
Country [1] 3475 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5786 0
Sydney South West Area Health Service (RPA Zone)
Ethics committee address [1] 5786 0
Research Development Office, Level 8 Building 14, RPA Hospital, Camperdown, NSW, 2050
Ethics committee country [1] 5786 0
Australia
Date submitted for ethics approval [1] 5786 0
Approval date [1] 5786 0
06/06/2008
Ethics approval number [1] 5786 0
X07-0290
Ethics committee name [2] 5787 0
Southern Health
Ethics committee address [2] 5787 0
Research Directorate, Level 4 Main Block, 246 Clayton Road, Clayton, Victoria 3168
Ethics committee country [2] 5787 0
Australia
Date submitted for ethics approval [2] 5787 0
Approval date [2] 5787 0
15/07/2008
Ethics approval number [2] 5787 0
07211C

Summary
Brief summary
This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadovist®) Injection and ProHance® Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance®.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28841 0
Address 28841 0
Country 28841 0
Phone 28841 0
Fax 28841 0
Email 28841 0
Contact person for public queries
Name 11998 0
Dr John Patava
Address 11998 0
875 Pacific Highway
Pymble, NSW 2073
Country 11998 0
Australia
Phone 11998 0
+61 2 93916195
Fax 11998 0
Email 11998 0
john.patava@bayerhealthcare.com
Contact person for scientific queries
Name 2926 0
Medical Services Manager
Address 2926 0
875 Pacific Highway
Pymble, NSW 2073
Country 2926 0
Australia
Phone 2926 0
+61 2 9391 6147
Fax 2926 0
Email 2926 0
medicalinformation@bayerhealthcare.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary