Clinical trial NCT03205280: Clinical Decision Support System (CADIMS) for MS Diagnostic
Official title: Assessment of a Clinical Decision Support System (CADIMS) for Improving Multiple Sclerosis Diagnostic Accuracy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis, Relapsing-Remitting, Computer-Assisted Diagnosis, MRI, Diagnosis, Treatment Efficacy
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Association Neuro-Bretagne
name: Institut National de Recherche en Informatique et en Automatique
name: Groupement de Coopération Sanitaire e-Santé Bretagne
name: Institut de Recherche Technologique b<>com
First posted: 2017-07-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Relapsing-remitting multiple sclerosis patients

Brief 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. 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.
2. Objective To evaluate the accuracy of MS lesions detection on cerebral MRI by comparing the CADIMS tool to the expert consensus.


Eligibility criteria: Inclusion Criteria:

* ≥ 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

Exclusion Criteria:

* Progressive MS
* no consent of the patient

Primary outcomes:
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
timeFrame: At the end of the enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Lorient
country: France
facility: Centre Hospitalier Bretagne Sud
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
city: Rennes
country: France
facility: Centre Hospitalier
city: Saint-Malo
country: France
facility: Centre d'imagerie médicale de la découverte
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
Study officials:
affiliation: Rennes University Hospital
name: Jean-Christophe FERRE, PhD
role: PRINCIPAL_INVESTIGATOR
References: