Clinical Decision Support System (CADIMS) for MS Diagnostic (POCADIMS)

Assessment of a Clinical Decision Support System (CADIMS) for Improving Multiple Sclerosis Diagnostic Accuracy

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Relapsing-Remitting

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Lorient, France, 56322
    • Centre Hospitalier Bretagne Sud
  • Rennes, France, 35000
    • Centre Hospitalier Universitaire de Rennes
  • Rennes, France, 35500
    • Centre Hospitalier
  • Saint-Malo, France, 35400
    • Centre d'imagerie médicale de la découverte
  • Vannes, France, 56017
    • Centre Hospitalier Bretagne Atlantique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Relapsing-remitting multiple sclerosis patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	At the end of the enrollment

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: Institut National de Recherche en Informatique et en Automatique; Association Neuro-Bretagne; Groupement de Coopération Sanitaire e-Santé Bretagne; Institut de Recherche Technologique b<>com
• Investigators: Principal Investigator: Jean-Christophe FERRE, PhD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): December 7, 2022
• Study Completion (Actual): December 7, 2022

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Multiple Sclerosis, Relapsing-Remitting, Computer-Assisted Diagnosis, MRI, Diagnosis, Treatment Efficacy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: 35RC16_8968 POCADIMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No