Multiple SclerosisNCT02992847
Evaluation of Potential Accumulation of Gadolinium (Dotarem and Multihance) in the French Observatory of Multiple Sclerosis (Www.Ofsep.Org/)
An observational study of Multiple Sclerosis, run by Hospices Civils de Lyon.
Trial summary
Several recent studies have shown an increase in the signal intensity of the unenhanced T1-weighted magnetic resonance images in the brain of patients with normal renal functions and a breakdown of the blood-brain barrier. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Unenhanced MRI
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the French observatory of multiple sclerosis (www.ofsep.org/)
Who may be able to join
- Clinical diagnosis of Multiple sclerosis
- At least 5 MR imaging with the same Gadolinium based contrast agent (either Dotarem or Multihance)
- Have performed an unenhanced T1-weighted image before Gadolinium based contrast agent injection according to the OFSEP protocol
Who cannot join
- Never experienced other contrast agent then the one specified by the group to which they belong (either Dotarem, or Multihance)
Trial locations and contacts
No sites are listed yet.
Stéphane KREMER, MD contact
About this study
Several recent studies have shown an increase in the signal intensity of the unenhanced T1-weighted magnetic resonance images in the brain of patients with normal renal functions and a breakdown of the blood-brain barrier. This hyper-intensity was specifically related to an accumulation of gadolinium based contrast agent. These studies were mainly conducted in patients with primary or secondary brain tumor. Multiple sclerosis is a particular model since it involves patients with a break of the blood-brain barrier, a long life expectancy, and who received many injections of contrast enhancing agents. In this context, it appears fundamental to know whether contrast agents accumulate in the brain for this disease. The French Observatory of Multiple Sclerosis is particularly suited to test this hypothesis, with homogeneous MRI data over several centers in France, and optimized sequences of 3D-T1 without injection. The purpose of this study is to evaluate the accumulation of two commonly used gadolinium based contrast materials (Dotarem and Multihance) in patients with multiple sclerosis, who received at least 5 injection of exclusively one of these contrast material.
- Conditions
- Multiple Sclerosis
- Being tested
- Unenhanced MRI
- Keywords
- Multiple sclerosis, Gadolinium based contrast agent, MRI, Dentate nucleus
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unenhanced MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Dotarem | At least 5 injection with Dotarem exclusively Receives: Other: Unenhanced MRI | |
| Multihance | At least 5 injection with Multihance exclusively Receives: Other: Unenhanced MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean signal intensity in the dentate nucleus, pons, globus pallidus, and thalamus on unenhanced T1-weighted images after unenhanced MRI (magnetic resonance imaging), (no measurement unit)
Operator defined region of interest measure of signal intensity on unenhanced T1-weighted images after MR acquisition
Measured: 12 months after last injection of contrast material for enhanced MR acquisition
Secondary outcomes (1)
EDSS (Expanded Disability Status Scale) score
Measured: 12 months after last injection of contrast material for enhanced MR acquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992847
- Sponsor's protocol ID
- 69HCL16_0646
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Potential Accumulation of Gadolinium (Dotarem and Multihance) in the French Observatory of Multiple Sclerosis (Www.Ofsep.Org/)
- ClinicalTrials.gov ID
- NCT02992847
- Acronym / sponsor ID
- 69HCL16_0646
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Gadolinium based contrast agent, MRI, Dentate nucleus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- Jan 2017
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 14 Dec 2016 (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.
Several recent studies have shown an increase in the signal intensity of the unenhanced T1-weighted magnetic resonance images in the brain of patients with normal renal functions and a breakdown of the blood-brain barrier. This hyper-intensity was specifically related to an accumulation of gadolinium based contrast agent. These studies were mainly conducted in patients with primary or secondary brain tumor. Multiple sclerosis is a particular model since it involves patients with a break of the blood-brain barrier, a long life expectancy, and who received many injections of contrast enhancing agents. In this context, it appears fundamental to know whether contrast agents accumulate in the brain for this disease. The French Observatory of Multiple Sclerosis is particularly suited to test this hypothesis, with homogeneous MRI data over several centers in France, and optimized sequences of 3D-T1 without injection. The purpose of this study is to evaluate the accumulation of two commonly used gadolinium based contrast materials (Dotarem and Multihance) in patients with multiple sclerosis, who received at least 5 injection of exclusively one of these contrast material.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dotarem | – | Other: Unenhanced MRIAt least 5 injection with Dotarem exclusively |
| Multihance | – | Other: Unenhanced MRIAt least 5 injection with Multihance exclusively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the French observatory of multiple sclerosis (www.ofsep.org/)
Key inclusion criteria (3 listed)
- Clinical diagnosis of Multiple sclerosis
- At least 5 MR imaging with the same Gadolinium based contrast agent (either Dotarem or Multihance)
- Have performed an unenhanced T1-weighted image before Gadolinium based contrast agent injection according to the OFSEP protocol
Key exclusion criteria (1 listed)
- Never experienced other contrast agent then the one specified by the group to which they belong (either Dotarem, or Multihance)
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 |
|---|---|---|
| Unenhanced MRI | Other | Dotarem, Multihance |
Primary outcome
Mean signal intensity in the dentate nucleus, pons, globus pallidus, and thalamus on unenhanced T1-weighted images after unenhanced MRI (magnetic resonance imaging), (no measurement unit)
Time frame: 12 months after last injection of contrast material for enhanced MR acquisition
Operator defined region of interest measure of signal intensity on unenhanced T1-weighted images after MR acquisition
1 secondary outcome
EDSS (Expanded Disability Status Scale) score
Time frame: 12 months after last injection of contrast material for enhanced MR acquisition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
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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.
Stéphane KREMER, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Hospices Civils de Lyon.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francçois COTTON, MD ((0)4 78 86 21 37 ext. +33, francois.cotton@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean signal intensity in the dentate nucleus, pons, globus pallidus, and thalamus on unenhanced T1-weighted images after unenhanced MRI (magnetic resonance imaging), (no measurement unit) (time frame: 12 months after last injection of contrast material for enhanced MR acquisition). 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 14 Dec 2016.