Central Nervous System DiseasesNCT03147989
Retrospective Study of MRI With MULTIHANCE at 0.10 and 0.05 mmol/Kg Dose in CNS Patients
An observational study of Central Nervous System Diseases and Central Nervous System Neoplasms, run by Bracco Diagnostics, Inc at 1 site in United States.
Trial summary
This is a retrospective study to collect already existing data and images from patients ≥ 2 years of age who had MRI for CNS diseases with MultiHance administration at a standard 0.10 mmol/kg dose or the half dose of 0.05 mmol/kg. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Central Nervous System Diseases, Central Nervous System Neoplasms
- What is being tested?
- MultiHance
- How many people
- 352 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2017to 16 Mar 2018
- Phase
- Observational
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients ≥ 2 years of age, having had a Multihance administration with either a dose of 0.10 mmol/kg or a dose of 0.05 mmol/kg for MRI of the CNS for a suspected or known extra-axial tumor at 1.5T, or suspected or known CNS disease at 3.0T.
Who may be able to join
- Was at least 2 years of age at the time of the MRI with MULTIHANCE injection at the dose of either 0.1 or 0.05 mmol/kg (±20% in volume administered).
- Has available demographic and safety data.
- Belongs to one of these 4 sub-groups:
- Had a documented known extra-axial lesion of the CNS and previously underwent MRI with a 1.5T magnet requiring an injection of 0.1 mmol/kg MULTIHANCE.
- Had a documented known extra-axial lesion of the CNS and previously underwent MRI with a 1.5T magnet requiring an injection of 0.05 mmol/kg MULTIHANCE.
- Had a documented known lesion of the CNS (including extra-axial) and previously underwent MRI with 3T magnet requiring an injection of 0.1 mmol/kg MULTIHANCE.
Show all 9Show fewer
- Had a documented known lesion of the CNS (including extra-axial) and previously underwent MRI with 3T magnet requiring an injection of 0.05 mmol/kg MULTIHANCE.
- Have both pre- and post-dose T1 SE/FSE, and/or GRE, and T2 SE/FSE, and FLAIR MR Images (when available).
- Has one of the two documented doses of MULTIHANCE (either 0.05 or 0.1 mmol/kg) administered for their MRI exam and/or the volume (mL) and weight of the patient available to be used to calculate the exact dose (mmol/kg) of MULTIHANCE that was administered.
Who cannot join
- Any patient who does not fulfill all of the inclusion criteria;
- Any patient who has been previously entered into this study. Patients must be enrolled only once into the study. Working backward chronologically from date of the final Protocol, if a patient has already been enrolled and appears in the PACs System again due to an earlier MRI, this patient must be excluded from the study (i.e., only the first qualifying MRI working backward chronologically from the date of the final Protocol should be included into the study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Parallel-Group Comparison of Two Doses Of Multihance (0.10 mmol/Kg and 0.05 mmol/Kg) When Used For Magnetic Resonance Imaging (MRI) of The Central Nervous System (CNS)
This is a retrospective study to collect already existing data and images from patients ≥ 2 years of age who had MRI for CNS diseases with MultiHance administration at a standard 0.10 mmol/kg dose or the half dose of 0.05 mmol/kg. The MRI images of all included patients will be prospectively reviewed in a blinded read to compare the efficacy of the two doses.
Read the detailed description
This study is retrospective in design in that the MR images and other patient data, such as demographic data, will be collected from existing data for the selected patients meeting the inclusion criteria defined in this protocol. The study will be a multicenter study comparing interindividually two groups, one group of patients having received MULTIHANCE at a standard dose of 0.10 mmol/kg and the other group a dose of 0.05 mmol/kg for their clinically indicated MRI examination.
In order to minimize selection bias, recruitment will start with the "Final Date" of this protocol and, working backward chronologically from all the MR examinations stored in the local site Picture Archiving and Communication Systems (PACS), every patient meeting the inclusion criteria will be recruited for the study until the total number of patients (160) in each group will be reached.
The images of all included patients will be prospectively reviewed in a blinded read.
- Being tested
- MultiHance
- Keywords
- MultiHance, MRI, CNS, Gadobenate Dimeglumine
- Medical subject headings
- Central Nervous System Diseases, Central Nervous System 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
gadolinium contrast agent
| Study group | Role | What they receive |
|---|---|---|
| Group 1, 0.10 mmol/kg | For patients having received MULTIHANCE at a standard dose of 0.10 mmol/kg for their clinically indicated MRI examination. Receives: Drug: MultiHance | |
| Group 2, 0.05 mmol/kg | For patients having received MULTIHANCE at a dose of 0.05 mmol/kg for their clinically indicated MRI examination. Receives: Drug: MultiHance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority in border delineation of lesions
To show non-inferiority of a 0.05 mmol/kg dose of MULTIHANCE as compared to 0.10 mmol/kg dose of MULTIHANCE, in patients undergoing contrast-enhanced MRI of the CNS in terms of lesion visualization based on pre-dose + post-dose: Border delineation of lesions
Measured: 1 Day
Non-inferiority in visualization of internal morphology of lesions
To show non-inferiority of a 0.05 mmol/kg dose of MULTIHANCE as compared to 0.10 mmol/kg dose of MULTIHANCE, in patients undergoing contrast-enhanced MRI of the CNS in terms of lesion visualization based on pre-dose + post-dose: visualization of internal morphology of lesions
Measured: 1 Day
Non-inferiority in contrast enhancement of lesions
To show non-inferiority of a 0.05 mmol/kg dose of MULTIHANCE as compared to 0.10 mmol/kg dose of MULTIHANCE, in patients undergoing contrast-enhanced MRI of the CNS in terms of lesion visualization based on pre-dose + post-dose: contrast enhancement of lesions
Measured: 1 Day
Secondary outcomes (5)
Comparison of patient level change in border delineation of lesions
To compare the efficacy of MULTIHANCE in MRI of the CNS in patients at a dose of 0.10 mmol/kg and 0.05 mmol/ kg in terms of patient level changes from pre-dose to pre + post-dose, with regard to border delineation of lesions.
Measured: 1 Day
Comparison of patient level change in visualization of internal morphology of lesions
To compare the efficacy of MULTIHANCE in MRI of the CNS in patients at a dose of 0.10 mmol/kg and 0.05 mmol/kg in terms of patient level changes from pre-dose to pre + post-dose, with regard to visualization of internal morphology of lesions
Measured: 1 Day
Comparison of patient level change in contrast enhancement of lesions
To compare the efficacy of MULTIHANCE in MRI of the CNS in patients at a dose of 0.10 mmol/kg and 0.05 mmol/kg in terms of patient level changes from pre-dose to pre + post-dose, with regard to contrast enhancement of lesions
Measured: 1 Day
Comparison of Lesion-to-brain ratio
To compare the two doses of MultiHance in terms of predose to postdose by lesion changes for up to the 3 largest lesions in Lesion-to-brain ratio
Measured: 1 Day
Comparison of contrast-to-noise ratio
To compare the two doses of MultiHance in terms of predose to postdose by lesion changes for up to the 3 largest lesions in Contrast-to-noise ratio
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start18 May 2017
- Primary completion7 Dec 2017
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System DiseasesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gianpaolo Priovano, MD, Study director, Bracco Diagnostics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147989
- Sponsor's protocol ID
- MH-151
- Status last verified
- Feb 2018
- First submitted
- 14 Apr 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel-Group Comparison of Two Doses Of Multihance (0.10 mmol/Kg and 0.05 mmol/Kg) When Used For Magnetic Resonance Imaging (MRI) of The Central Nervous System (CNS)
- ClinicalTrials.gov ID
- NCT03147989
- Acronym / sponsor ID
- MH-151
- Keywords
- MultiHance, MRI, CNS, Gadobenate Dimeglumine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- 18 May 2017 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 10 May 2017 (actual)
- 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 is a retrospective study to collect already existing data and images from patients ≥ 2 years of age who had MRI for CNS diseases with MultiHance administration at a standard 0.10 mmol/kg dose or the half dose of 0.05 mmol/kg. The MRI images of all included patients will be prospectively reviewed in a blinded read to compare the efficacy of the two doses.
Detailed description
This study is retrospective in design in that the MR images and other patient data, such as demographic data, will be collected from existing data for the selected patients meeting the inclusion criteria defined in this protocol. The study will be a multicenter study comparing interindividually two groups, one group of patients having received MULTIHANCE at a standard dose of 0.10 mmol/kg and the other group a dose of 0.05 mmol/kg for their clinically indicated MRI examination.
In order to minimize selection bias, recruitment will start with the "Final Date" of this protocol and, working backward chronologically from all the MR examinations stored in the local site Picture Archiving and Communication Systems (PACS), every patient meeting the inclusion criteria will be recruited for the study until the total number of patients (160) in each group will be reached.
The images of all included patients will be prospectively reviewed in a blinded read.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1, 0.10 mmol/kg | – | Drug: MultiHanceFor patients having received MULTIHANCE at a standard dose of 0.10 mmol/kg for their clinically indicated MRI examination. |
| Group 2, 0.05 mmol/kg | – | Drug: MultiHanceFor patients having received MULTIHANCE at a dose of 0.05 mmol/kg for their clinically indicated MRI examination. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients ≥ 2 years of age, having had a Multihance administration with either a dose of 0.10 mmol/kg or a dose of 0.05 mmol/kg for MRI of the CNS for a suspected or known extra-axial tumor at 1.5T, or suspected or known CNS disease at 3.0T.
Key inclusion criteria (9 listed)
- Was at least 2 years of age at the time of the MRI with MULTIHANCE injection at the dose of either 0.1 or 0.05 mmol/kg (±20% in volume administered).
- Has available demographic and safety data.
- Belongs to one of these 4 sub-groups:
- Have both pre- and post-dose T1 SE/FSE, and/or GRE, and T2 SE/FSE, and FLAIR MR Images (when available).
- Has one of the two documented doses of MULTIHANCE (either 0.05 or 0.1 mmol/kg) administered for their MRI exam and/or the volume (mL) and weight of the patient available to be used to calculate the exact dose (mmol/kg) of MULTIHANCE that was administered.
Key exclusion criteria (2 listed)
- Any patient who does not fulfill all of the inclusion criteria;
- Any patient who has been previously entered into this study. Patients must be enrolled only once into the study. Working backward chronologically from date of the final Protocol, if a patient has already been enrolled and appears in the PACs System again due to an earlier MRI, this patient must be excluded from the study (i.e., only the first qualifying MRI working backward chronologically from the date of the final Protocol should be included into the study).
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 Dimegluminegadolinium contrast agent | Drug | Group 1, 0.10 mmol/kg, Group 2, 0.05 mmol/kg |
Primary outcome
Non-inferiority in border delineation of lesions
Time frame: 1 Day
To show non-inferiority of a 0.05 mmol/kg dose of MULTIHANCE as compared to 0.10 mmol/kg dose of MULTIHANCE, in patients undergoing contrast-enhanced MRI of the CNS in terms of lesion visualization based on pre-dose + post-dose: Border delineation of lesions
Non-inferiority in visualization of internal morphology of lesions
Time frame: 1 Day
To show non-inferiority of a 0.05 mmol/kg dose of MULTIHANCE as compared to 0.10 mmol/kg dose of MULTIHANCE, in patients undergoing contrast-enhanced MRI of the CNS in terms of lesion visualization based on pre-dose + post-dose: visualization of internal morphology of lesions
Non-inferiority in contrast enhancement of lesions
Time frame: 1 Day
To show non-inferiority of a 0.05 mmol/kg dose of MULTIHANCE as compared to 0.10 mmol/kg dose of MULTIHANCE, in patients undergoing contrast-enhanced MRI of the CNS in terms of lesion visualization based on pre-dose + post-dose: contrast enhancement of lesions
5 secondary outcomes
Comparison of patient level change in border delineation of lesions
Time frame: 1 Day
Comparison of patient level change in visualization of internal morphology of lesions
Time frame: 1 Day
Comparison of patient level change in contrast enhancement of lesions
Time frame: 1 Day
Comparison of Lesion-to-brain ratio
Time frame: 1 Day
Comparison of contrast-to-noise ratio
Time frame: 1 Day
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 18 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Central Nervous System Diseases
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
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, 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?
An observational study of Central Nervous System Diseases and Central Nervous System Neoplasms, 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 9 inclusion and 2 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 18 Jul 2018. 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.
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?
Non-inferiority in border delineation of lesions (time frame: 1 Day). The study lists 3 primary outcomes in all. 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 18 Jul 2018.