Multiple Sclerosis, Relapsing-RemittingPOCADIMSNCT03205280
Clinical Decision Support System (CADIMS) for MS Diagnostic
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Rennes University Hospital at 5 sites in France.
Trial summary
1. Background The results obtained in clinical research led to a new paradigm for the treatment of patients affected with multiple sclerosis (MS): "no evidence of disease activity". This means having each patient monitored with high quality imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- How many people
- 200 participants
- Where
- 5 sitesFrance
- Study dates
- 11 Oct 2017to 7 Dec 2022
- 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: Relapsing-remitting multiple sclerosis patients
Who may be able to join
- ≥ 18 years-old
- Patient with relapsing-remitting multiple sclerosis, according to the 2010 Mc Donald's criteria
- EDSS<4
- Disease duration < 10 years
- To insure a clinical demand of 2 brain MRIs within 12 months of the installation of an immunomodulatory therapy
- MRI brain scanner acquired according to the OFSEP recommendations installation of an immunomodulatory therapy
Who cannot join
- Progressive MS
- no consent of the patient
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Hospitalier Bretagne Sud
Lorient, 56322
Centre Hospitalier Universitaire de Rennes
Rennes, 35000
Centre Hospitalier
Rennes, 35500
Centre d'imagerie médicale de la découverte
St-Malo, 35400
Centre Hospitalier Bretagne Atlantique
Vannes, 56017
About this study
Official title: Assessment of a Clinical Decision Support System (CADIMS) for Improving Multiple Sclerosis Diagnostic Accuracy
- Background The results obtained in clinical research led to a new paradigm for the treatment of patients affected with multiple sclerosis (MS): "no evidence of disease activity". This means having each patient monitored with high quality imaging. To this purpose, researchers have developed segmentation algorithms for automated reading of MRIs, facilitating longitudinal comparisons, and allowing an accurate assessment of the number and the volume of focal lesions. We have thus a powerful strategic biomarker for the treatment of MS. Due to the relevance of comparing over time the evolution of lesions (lesion load) and brain atrophy, the French Society of Neuroradiology edited standardized national recommendations. The MS French Observatory (OFSEP) has adopted these recommendations, in order to harmonize exams for all patients all over the country. At an international level as well, MRI have been put at the heart of the therapeutic strategy. Therefore, we need now to create the conditions able to implement, collect and analyze imaging data according to these recommendations. This is the meaning of the MUSIC project, which aims to develop and assess a standardized monitoring MRI control tool for therapeutic decision. CADIMS is this tool. It is based on an integration of several segmentation algorithms developed by INRIA and an image viewer developed by b<>com and included in a regional images-sharing server ETIAM Nexus. This tool is a help showing segmented brain T2 lesions, gadolinium-enhanced T1 lesions and news T2 lesions appeared from the previous MRI exam, in a multicenter clinical context.
- Objective To evaluate the accuracy of MS lesions detection on cerebral MRI by comparing the CADIMS tool to the expert consensus.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Computer-Assisted Diagnosis, MRI, Diagnosis, Treatment Efficacy
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance among the number of new T2 lesions, the total number of T2 lesions and the number of gadolinium enhanced lesions on brain MRIs identified by the CADIMS tool and by the expert consensus
Measured: At the end of the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start11 Oct 2017
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Association Neuro-Bretagne, Institut National de Recherche en Informatique et en Automatique, Groupement de Coopération Sanitaire e-Santé Bretagne, Institut de Recherche Technologique b<>com
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe FERRE, PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205280
- Sponsor's protocol ID
- 35RC16_8968 POCADIMS
- Acronym
- POCADIMS
- Status last verified
- Sep 2018
- First submitted
- 28 Jun 2017
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Clinical Decision Support System (CADIMS) for Improving Multiple Sclerosis Diagnostic Accuracy
- ClinicalTrials.gov ID
- NCT03205280
- Acronym / sponsor ID
- POCADIMS / 35RC16_8968 POCADIMS
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Computer-Assisted Diagnosis, MRI, Diagnosis, Treatment Efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Association Neuro-Bretagne, Institut National de Recherche en Informatique et en Automatique, Groupement de Coopération Sanitaire e-Santé Bretagne, Institut de Recherche Technologique b<>com
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 2 Jul 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.
- Background The results obtained in clinical research led to a new paradigm for the treatment of patients affected with multiple sclerosis (MS): "no evidence of disease activity". This means having each patient monitored with high quality imaging. To this purpose, researchers have developed segmentation algorithms for automated reading of MRIs, facilitating longitudinal comparisons, and allowing an accurate assessment of the number and the volume of focal lesions. We have thus a powerful strategic biomarker for the treatment of MS. Due to the relevance of comparing over time the evolution of lesions (lesion load) and brain atrophy, the French Society of Neuroradiology edited standardized national recommendations. The MS French Observatory (OFSEP) has adopted these recommendations, in order to harmonize exams for all patients all over the country. At an international level as well, MRI have been put at the heart of the therapeutic strategy. Therefore, we need now to create the conditions able to implement, collect and analyze imaging data according to these recommendations. This is the meaning of the MUSIC project, which aims to develop and assess a standardized monitoring MRI control tool for therapeutic decision. CADIMS is this tool. It is based on an integration of several segmentation algorithms developed by INRIA and an image viewer developed by b<>com and included in a regional images-sharing server ETIAM Nexus. This tool is a help showing segmented brain T2 lesions, gadolinium-enhanced T1 lesions and news T2 lesions appeared from the previous MRI exam, in a multicenter clinical context.
- Objective To evaluate the accuracy of MS lesions detection on cerebral MRI by comparing the CADIMS tool to the expert consensus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Relapsing-remitting multiple sclerosis patients
Key inclusion criteria (6 listed)
- ≥ 18 years-old
- Patient with relapsing-remitting multiple sclerosis, according to the 2010 Mc Donald's criteria
- EDSS<4
- Disease duration < 10 years
- To insure a clinical demand of 2 brain MRIs within 12 months of the installation of an immunomodulatory therapy
Key exclusion criteria (2 listed)
- Progressive MS
- no consent of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance among the number of new T2 lesions, the total number of T2 lesions and the number of gadolinium enhanced lesions on brain MRIs identified by the CADIMS tool and by the expert consensus
Time frame: At the end of the enrollment
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 12 Apr 2023.
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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.
Jean-Christophe FERRE, PhD principal investigator
Rennes University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Rennes University Hospital at 5 sites in France.
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 6 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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Concordance among the number of new T2 lesions, the total number of T2 lesions and the number of gadolinium enhanced lesions on brain MRIs identified by the CADIMS tool and by the expert consensus (time frame: At the end of the enrollment). 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 12 Apr 2023; AzTrials last refreshed its copy on 4 Nov 2026.