Brain DiseasePhase 4BENEFITNCT02070380
Crossover Comparison of MultiHance and Dotarem
A Phase 4 study testing MultiHance 0.1 mmol/kg, Dotarem and MultiHance 0.05 mmol/kg in people with Brain Disease, run by Bracco Diagnostics, Inc at 1 site in United States.
Trial summary
This study aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of MultiHance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Disease
- What is being tested?
- MultiHance 0.1 mmol/kg, Dotarem and MultiHance 0.05 mmol/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Mar 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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:
- Clinical/neurological symptomatology;
- Diagnostic testing, such as CT or previous MRI examinations; or
- Have had recent brain surgery and are to be evaluated for recurrence
Who cannot join
- Are pregnant or lactating females. Exclude the possibility of pregnancy:
- By testing on site at the institution within 24 hours prior to the start of each investigational product administration; or
- By history (i.e., tubal ligation or hysterectomy); or
- Post menopausal with a minimum of 1 year without menses
- Have any known allergy to one or more of the ingredients in the investigational products, or have a history of hypersensitivity to any metals
- Have congestive heart failure (class IV according to the classification of the New York Heart Association)
Show all 18Show fewer
- Have suffered a stroke within a year
- Have received or are scheduled to receive any other contrast medium in the 24 hours preceding through the 24 hours following Exam 1, and in the 24 hours preceding through the 24 hours 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 hours post-administration of the second investigational product
- Have moderate-to-severe renal impairment, defined as Glomerular Filtration Rate (GFR)/estimated GFR < 45 mL/min
- Have been previously entered into this study
- Have received or are scheduled for one of the following:
- Surgical or chemotherapeutic treatment 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, Two-Arm Crossover Study to Compare 0.1 mmol/kg of MultiHance With 0.1 mmol/kg of Dotarem and 0.05 mmol/kg of MultiHance With 0.1 mmol/kg of Dotarem in MRI of the Brain
This study aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of MultiHance.
Read the detailed description
This crossover study aims at a comparison between 0.1 mmol/kg MultiHance and 0.1 mmol/kg Dotarem, between 0.05 MultiHance and 0.1 mmol/kg Dotarem in terms of diagnostic preference at CE-MRI in brain tumor patients to show superiority of MultiHance.
- Conditions
- Brain Disease
- Being tested
- MultiHance 0.1 mmol/kg, Dotarem, MultiHance 0.05 mmol/kg
- Keywords
- confirmed brain disease, highly suspected brain disease
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultiHance 0.1 mmol/kgDrug
MultiHance administered at 0.1 mmol/kg
DotaremDrug
Also called Dotarem 0.1 mmol/kg
Dotarem administered at 0.1 mmol/kg
MultiHance 0.05 mmol/kgDrug
MultiHance administered at 0.05 mmol/kg
| Study group | Role | What they receive |
|---|---|---|
| MultiHance 0.1 then Dotarem 0.1 mmol/kg | Experimental | MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg Receives: Drug: MultiHance 0.1 mmol/kg; Drug: Dotarem |
| MultiHance 0.05 then Dotarem 0.1 mmol/kg | Experimental | MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg Receives: Drug: Dotarem; Drug: MultiHance 0.05 mmol/kg |
| Dotarem 0.1 then MultiHance 0.1 mmol/kg | Active comparator | Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg Receives: Drug: MultiHance 0.1 mmol/kg; Drug: Dotarem |
| Dotarem 0.1 then MultiHance 0.05 mmol/kg | Active comparator | Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg Receives: Drug: Dotarem; Drug: MultiHance 0.05 mmol/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Diagnostic Preference Between the Two Exams
Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.
Measured: Comparison of image sets obtained within 2 to 14 days
Secondary outcomes (6)
Lesion Border Delineation
Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.
Measured: Comparison of image sets obtained within 2 to 14 days
Lesion Internal Morphology
Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.
Measured: Comparison of image sets obtained within 2 to 14 days
Extent of Disease
Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.
Measured: Comparison of image sets obtained within 2 to 14 days
Lesion Contrast Enhancement
Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.
Measured: Comparison of image sets obtained within 2 to 14 days
Lesion to Background Ratio on Post T1-weighed Spin Echo Images
The Unit of Measure is lesion-to-background ratio based on lesions assessed. For each lesion, Lesion-to-background ratio (LBR) = SI of lesion/SI of brain. Firstly, LBR of each lesion was assessed for each contrast agent postdose image separately, then the difference in LBR between MultiHance and Dotarem was calculated. The number presented in the result table below is "the mean difference in LBR postdose (MultiHance - Dotarem)"
Measured: 5-10 minutes Postdose
Lesion-brain Contrast-to-noise Ratio
The Unit of Measure is contrast-to-noise ratio based on lesions assessed. For each lesion, Lesion-brain Contrast-to-noise Ratio (CNR) = [(SI of lesion - SI of brain)/SD for SI of noise] on Postdose Images of each lesion was calculated for each contrast agent image separately, then the difference in CNR between MultiHance and Dotarem was calculated. The number presented in the result table below is "the mean difference in CNR (MultiHance - Dotarem)"
Measured: 5-10 minutes Postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 179 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, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070380
- Sponsor's protocol ID
- MH-148
- Acronym
- BENEFIT
- Status last verified
- Nov 2016
- First submitted
- 20 Feb 2014
- Last updated
- 10 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Double Blind, Multi-Center, Randomized, Two-Arm Crossover Study to Compare 0.1 mmol/kg of MultiHance With 0.1 mmol/kg of Dotarem and 0.05 mmol/kg of MultiHance With 0.1 mmol/kg of Dotarem in MRI of the Brain
- ClinicalTrials.gov ID
- NCT02070380
- Acronym / sponsor ID
- BENEFIT / MH-148
- Conditions
- Brain Disease
- Keywords
- confirmed brain disease, highly suspected brain disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Posted 10 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of MultiHance.
Detailed description
This crossover study aims at a comparison between 0.1 mmol/kg MultiHance and 0.1 mmol/kg Dotarem, between 0.05 MultiHance and 0.1 mmol/kg Dotarem in terms of diagnostic preference at CE-MRI in brain tumor patients to show superiority of MultiHance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MultiHance 0.1 then Dotarem 0.1 mmol/kg | Experimental | Drug: MultiHance 0.1 mmol/kg, Drug: DotaremMultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg |
| MultiHance 0.05 then Dotarem 0.1 mmol/kg | Experimental | Drug: Dotarem, Drug: MultiHance 0.05 mmol/kgMultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg |
| Dotarem 0.1 then MultiHance 0.1 mmol/kg | Active comparator | Drug: MultiHance 0.1 mmol/kg, Drug: DotaremDotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg |
| Dotarem 0.1 then MultiHance 0.05 mmol/kg | Active comparator | Drug: Dotarem, Drug: MultiHance 0.05 mmol/kgDotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (18 listed)
- Are pregnant or lactating females. Exclude the possibility of pregnancy:
- By testing on site at the institution within 24 hours prior to the start of each investigational product administration; or
- By history (i.e., tubal ligation or hysterectomy); or
- Post menopausal with a minimum of 1 year without menses
- Have any known allergy to one or more of the ingredients in the investigational products, or have a history of hypersensitivity to any metals
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 0.1 mmol/kgMultiHance administered at 0.1 mmol/kg | Drug | Dotarem 0.1 then MultiHance 0.1 mmol/kg, MultiHance 0.1 then Dotarem 0.1 mmol/kg |
| DotaremAlso: Dotarem 0.1 mmol/kgDotarem administered at 0.1 mmol/kg | Drug | Dotarem 0.1 then MultiHance 0.05 mmol/kg, Dotarem 0.1 then MultiHance 0.1 mmol/kg, MultiHance 0.05 then Dotarem 0.1 mmol/kg, MultiHance 0.1 then Dotarem 0.1 mmol/kg |
| MultiHance 0.05 mmol/kgMultiHance administered at 0.05 mmol/kg | Drug | Dotarem 0.1 then MultiHance 0.05 mmol/kg, MultiHance 0.05 then Dotarem 0.1 mmol/kg |
Primary outcome
Global Diagnostic Preference Between the Two Exams
Time frame: Comparison of image sets obtained within 2 to 14 days
Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.
6 secondary outcomes
Lesion Border Delineation
Time frame: Comparison of image sets obtained within 2 to 14 days
Lesion Internal Morphology
Time frame: Comparison of image sets obtained within 2 to 14 days
Extent of Disease
Time frame: Comparison of image sets obtained within 2 to 14 days
Lesion Contrast Enhancement
Time frame: Comparison of image sets obtained within 2 to 14 days
Lesion to Background Ratio on Post T1-weighed Spin Echo Images
Time frame: 5-10 minutes Postdose
Lesion-brain Contrast-to-noise Ratio
Time frame: 5-10 minutes Postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Brain Disease
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
RecruitingPhase 2/3
A Study of Buntanetap in Participants With PD
Parkinson's Disease (PD), Deep Brain Stimulation
Not yet recruitingObservational study
Ultra-high-performance Positron Emission Tomography (PET) of Synaptic Density, Reactive Astrogliosis and Tau in Alzheimer's Disease
Alzheimer's Disease, Healthy Adult Participants
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
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, Inc
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 0.1 mmol/kg, Dotarem and MultiHance 0.05 mmol/kg in people with Brain Disease, run by Bracco Diagnostics, Inc at 1 site in United States.
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 8 inclusion and 18 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 10 Jan 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Global Diagnostic Preference Between the Two Exams (time frame: Comparison of image sets obtained within 2 to 14 days). 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 10 Jan 2017; AzTrials last refreshed its copy on 1 Nov 2026.