Brain TumorPhase 4NCT00395863
Multihance at 3 Tesla (3T) in Brain Tumors
A Phase 4 study testing Multihance and Arm 2 - Magnevist in people with Brain Tumor, run by Bracco Diagnostics, Inc at 1 site in United States.
Trial summary
Compare the efficacy of MultiHance and Magnevist Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Multihance and Arm 2 - Magnevist
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Mar 2008
- 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
- Was 18 years or older
- Provided written informed consent
- Scheduled for MRI
- Confirmed or highly suspected to have brain tumor(s) and willing to undergo two MRI exams within 14 days
Who cannot join
- Pregnant or lactating females
- Allergy to one or more of the ingredients in the products or hypersensitivity to any metals
- Congestive heart failure, class IV
- Previous stroke in the past year
- Received another contrast agent within 24 hours pre and post each exam
- Investigational product
Show all 10Show fewer
- Contraindications to MRI
- Severe claustrophobia
- Surgery with 3 weeks prior
- Steroid therapy or radiosurgery between two exams
Trial locations and contacts
1 site in 1 country.
United States1 site
Bracco Diagnostics, Inc.
Princeton, New Jersey, 08540
About this study
Official title: A Phase IV Double-blind Multicenter Randomized Crossover Study to Compare 0.10 mmol/kg of Multihance With 0.10 mmol.kg of Magnevist in Magnetic Resonance Imaging(MRI) of the Brain at 3T
Compare the efficacy of MultiHance and Magnevist
Read the detailed description
The purpose of this study was to evaluate whether Multihance is superior to Magnevist in terms of qualitative and quantitative assessment of unenhanced MRI and contrast-enhanced MRI for the visualization of brain disease.
- Conditions
- Brain Tumor
- Being tested
- Multihance, Arm 2 - Magnevist
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultihanceDrug
Also called gadobenate dimeglumine
0.5 M at a single injection
Arm 2 - MagnevistDrug
Also called gadopentetate dimeglumine
0.5 M Magnevist at a single dose injection
| Study group | Role | What they receive |
|---|---|---|
| MultiHance | Active comparator | 0.5 M MultiHance at a single injection Receives: Drug: Multihance |
| Magnevist | Active comparator | 0.5 M Magnevist at a single injection Receives: Drug: Arm 2 - Magnevist |
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 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred. Each patient's image was reviewed by 3 readers.
Measured: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Secondary outcomes (11)
Lesion Border Delineation
Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred.
Measured: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Lesion Contrast Enhancement Between the Two Exams
Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred.
Measured: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1
Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Measured: Predose and immediately postdose
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2
Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Measured: Predose and immediately postdose
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3
Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Measured: Predose and immediately postdose
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Measured: Predose and immediately postdose
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Measured: Predose and immediately postdose
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Measured: Predose and immediately postdose
Percentage of Lesion Contrast Enhancement (LCE) - Reader 1
Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]
Measured: Postdose
Percentage of Contrast Enhancement of the Lesion - Reader 2
Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]
Measured: Postdose
Percentage of Contrast Enhancement of the Lesion - Reader 3
Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]
Measured: Postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionFeb 2008
- Study completionMar 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gianpaolo Priovano, M.D., Study director, Bracco Diagnostics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395863
- Sponsor's protocol ID
- MH 126
- Status last verified
- Mar 2015
- First submitted
- 12 Sep 2006
- Last updated
- 5 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rumboldt Z, Rowley HA, Steinberg F, Maldjian JA, Ruscalleda J, Gustafsson L, Bastianello S. Multicenter, double-blind, randomized, intra-individual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine in MRI of brain tumors at 3 tesla. J Magn Reson Imaging. 2009 Apr;29(4):760-7. doi: 10.1002/jmri.21695.
PubMed 19306364
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Double-blind Multicenter Randomized Crossover Study to Compare 0.10 mmol/kg of Multihance With 0.10 mmol.kg of Magnevist in Magnetic Resonance Imaging(MRI) of the Brain at 3T
- ClinicalTrials.gov ID
- NCT00395863
- Acronym / sponsor ID
- MH 126
- Conditions
- Brain Tumor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 6 Nov 2006 (estimated)
- Results
- Posted 31 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the efficacy of MultiHance and Magnevist
Detailed description
The purpose of this study was to evaluate whether Multihance is superior to Magnevist in terms of qualitative and quantitative assessment of unenhanced MRI and contrast-enhanced MRI for the visualization of brain disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MultiHance | Active comparator | Drug: Multihance0.5 M MultiHance at a single injection |
| Magnevist | Active comparator | Drug: Arm 2 - Magnevist0.5 M Magnevist at a single injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Was 18 years or older
- Provided written informed consent
- Scheduled for MRI
- Confirmed or highly suspected to have brain tumor(s) and willing to undergo two MRI exams within 14 days
Key exclusion criteria (10 listed)
- Pregnant or lactating females
- Allergy to one or more of the ingredients in the products or hypersensitivity to any metals
- Congestive heart failure, class IV
- Previous stroke in the past year
- Received another contrast agent within 24 hours pre and post each exam
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 |
|---|---|---|
| MultihanceAlso: gadobenate dimeglumine0.5 M at a single injection | Drug | MultiHance |
| Arm 2 - MagnevistAlso: gadopentetate dimeglumine0.5 M Magnevist at a single dose injection | Drug | Magnevist |
Primary outcome
Global Diagnostic Preference Between the Two Exams
Time frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred. Each patient's image was reviewed by 3 readers.
11 secondary outcomes
Lesion Border Delineation
Time frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Lesion Contrast Enhancement Between the Two Exams
Time frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1
Time frame: Predose and immediately postdose
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2
Time frame: Predose and immediately postdose
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3
Time frame: Predose and immediately postdose
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1
Time frame: Predose and immediately postdose
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2
Time frame: Predose and immediately postdose
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3
Time frame: Predose and immediately postdose
Percentage of Lesion Contrast Enhancement (LCE) - Reader 1
Time frame: Postdose
Percentage of Contrast Enhancement of the Lesion - Reader 2
Time frame: Postdose
Percentage of Contrast Enhancement of the Lesion - Reader 3
Time frame: Postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19306364Rumboldt Z, Rowley HA, Steinberg F, Maldjian JA, Ruscalleda J, Gustafsson L, Bastianello S. Multicenter, double-blind, randomized, intra-individual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine in MRI of brain tumors at 3 tesla. J Magn Reson Imaging. 2009 Apr;29(4):760-7. doi: 10.1002/jmri.21695.
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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 Priovano, M.D. 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 and Arm 2 - Magnevist in people with Brain Tumor, 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 4 inclusion and 10 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 Nov 2020. 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 31 Jul 2009). 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: Postdose Images for MultiHance Exam and for Magnevist Exam Compared). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00395863, which also lists 1 linked publication.
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 Nov 2020.