Brain LesionsPhase 4MERITNCT00907530
Study to Compare MultiHance With Gadovist in Magnetic Resonance Imaging (MRI) of the Brain
A Phase 4 study testing MULTIHANCE: and GADOVIST in people with Brain Lesions, run by Bracco Diagnostics, Inc at 1 site in Canada.
Trial summary
This study is being conducted as a phase IV, double-blind, multi-center, randomized, crossover trial aimed at a within-subject comparison of MULTIHANCE and GADOVIST at a dose of 0.1 mmol/kg, in terms of qualitative and quantitative assessment of unenhanced MRI (UE MRI) and contrast-enhanced MRI (CE MRI) for the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Lesions
- What is being tested?
- MULTIHANCE: and GADOVIST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Jul 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enroll subjects in this study if they meet the following inclusion criteria:
- Are at least 18 years of age or older
- Are able to give written informed consent and are willing to comply with the protocol requirements
- Are scheduled to undergo MRI
- Are willing to undergo two MRI procedures within 14 days
- Have confirmed or are highly suspected to have brain tumor(s) (primary or secondary), as determined by:
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- clinical/neurological symptomatology;
- diagnostic testing, such as CT or previous MRI examinations; or
- have had recent surgery within 6 months and are to be evaluated for recurrence.
Who cannot join
- Exclude subjects from this study if they do not fulfill the inclusion criteria, or if any of the following conditions are observed.
- Are pregnant or lactating females. Exclude the possibility of pregnancy:
- by testing on site at the institution (serum or urine bHCG) within 24 h prior to the start of each investigational product administration
- by history (i.e., tubal ligation or hysterectomy)
- post menopausal with a minimum of 1 year without menses
- Have any known allergy to one or more of the ingredients in the investigational product, or have a history of hypersensitivity to any metals
Show all 19Show fewer
- Have congestive heart failure (class IV according to the classification of the New York Heart Association
- Have suffered a stroke within a year
- Have received or are scheduled to receive any other contrast medium in the 24 h preceding through the 24 h following Exam 1, and in the 24 h preceding through the 24 h following Exam 2
- Have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 h post-administration of the second investigational product.
- Have moderate-to-severe renal impairment, defined as a GFR/eGFR < 60 mL/min.
- Have been previously entered into this study
- Have received or are scheduled for one of the following:
- Surgery within three weeks prior to the first examination or between the two examinations
- Initiation of steroid therapy between the two examinations
- Radiosurgery between the two examinations
- Have any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field.
- Are suffering from severe claustrophobia
- Have any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV, Double-Blind, Multi-Center, Randomized, Crossover Study to Compare 0.1 mmol/kg OF MULTIHANCE® WITH 0.1 mmol/kg OF GADOVIST® in Magnetic Resonance Imaging (MRI) of the Brain
This study is being conducted as a phase IV, double-blind, multi-center, randomized, crossover trial aimed at a within-subject comparison of MULTIHANCE and GADOVIST at a dose of 0.1 mmol/kg, in terms of qualitative and quantitative assessment of unenhanced MRI (UE MRI) and contrast-enhanced MRI (CE MRI) for the visualization of brain disease.
- Conditions
- Brain Lesions
- Being tested
- MULTIHANCE:, GADOVIST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MULTIHANCE:Drug
MULTIHANCE ® 0.5 M,0.1 mmol/kg
GADOVISTDrug
GADOVIST ® 1.0 M,0.1 mmol/kg
| Study group | Role | What they receive |
|---|---|---|
| MULTIHANCE | Active comparator | gadobenate dimeglumine Receives: Drug: MULTIHANCE: |
| GADOVIST | Active comparator | gadobutrol Receives: Drug: GADOVIST |
What is being measured
The primary outcome is the main question the study is designed to answer.
To show superiority of a 0.1 mmol/kg dose of MULTIHANCE as compared to 0.1 mmol/kg dose of GADOVIST, in terms of the by-subject global diagnostic preference between exams (i.e., based on predose + postdose image sets).
Measured: Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gianpaolo Pirovano, MD, Study director, Bracco Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907530
- Sponsor's protocol ID
- MH-123
- Acronym
- MERIT
- Status last verified
- Jan 2012
- First submitted
- 20 May 2009
- Last updated
- 5 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Double-Blind, Multi-Center, Randomized, Crossover Study to Compare 0.1 mmol/kg OF MULTIHANCE® WITH 0.1 mmol/kg OF GADOVIST® in Magnetic Resonance Imaging (MRI) of the Brain
- ClinicalTrials.gov ID
- NCT00907530
- Acronym / sponsor ID
- MERIT / MH-123
- Conditions
- Brain Lesions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted as a phase IV, double-blind, multi-center, randomized, crossover trial aimed at a within-subject comparison of MULTIHANCE and GADOVIST at a dose of 0.1 mmol/kg, in terms of qualitative and quantitative assessment of unenhanced MRI (UE MRI) and contrast-enhanced MRI (CE MRI) for the visualization of brain disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MULTIHANCE | Active comparator | Drug: MULTIHANCE:gadobenate dimeglumine |
| GADOVIST | Active comparator | Drug: GADOVISTgadobutrol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Enroll subjects in this study if they meet the following inclusion criteria:
- Are at least 18 years of age or older
- Are able to give written informed consent and are willing to comply with the protocol requirements
- Are scheduled to undergo MRI
- Are willing to undergo two MRI procedures within 14 days
Key exclusion criteria (19 listed)
- Exclude subjects from this study if they do not fulfill the inclusion criteria, or if any of the following conditions are observed.
- Are pregnant or lactating females. Exclude the possibility of pregnancy:
- by testing on site at the institution (serum or urine bHCG) within 24 h prior to the start of each investigational product administration
- by history (i.e., tubal ligation or hysterectomy)
- post menopausal with a minimum of 1 year without menses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MULTIHANCE:MULTIHANCE ® 0.5 M,0.1 mmol/kg | Drug | MULTIHANCE |
| GADOVISTGADOVIST ® 1.0 M,0.1 mmol/kg | Drug | GADOVIST |
Primary outcome
To show superiority of a 0.1 mmol/kg dose of MULTIHANCE as compared to 0.1 mmol/kg dose of GADOVIST, in terms of the by-subject global diagnostic preference between exams (i.e., based on predose + postdose image sets).
Time frame: Day 1 and Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianpaolo Pirovano, MD study director
Bracco Diagnostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MULTIHANCE: and GADOVIST in people with Brain Lesions, run by Bracco Diagnostics, Inc at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To show superiority of a 0.1 mmol/kg dose of MULTIHANCE as compared to 0.1 mmol/kg dose of GADOVIST, in terms of the by-subject global diagnostic preference between exams (i.e., based on predose + postdose image sets). (time frame: Day 1 and Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2012; AzTrials last refreshed its copy on 7 Nov 2026.