Clinical Decision Support System (CADIMS) for MS Diagnostic

NCT03205280 | Completed

• 1 other identifier: 35RC16_8968 POCADIMS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

Brief Summary

1. 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.
2. 2.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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Relapsing-remitting multiple sclerosis patients

You may qualify if:

• ≥ 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

You may not qualify if:

• Progressive MS
• no consent of the patient

Sponsors & Collaborators

• Rennes University Hospital: lead
• Association Neuro-Bretagne: collaborator
• Institut National de Recherche en Informatique et en Automatique: collaborator
• Groupement de Coopération Sanitaire e-Santé Bretagne: collaborator
• Institut de Recherche Technologique b<>com: collaborator

Study Sites (5)

Centre Hospitalier Bretagne Sud

Lorient, 56322, France

Location

Centre Hospitalier Universitaire de Rennes

Rennes, 35000, France

Location

Centre Hospitalier

Rennes, 35500, France

Location

Centre d'imagerie médicale de la découverte

St-Malo, 35400, France

Location

Centre Hospitalier Bretagne Atlantique

Vannes, 56017, France

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Disease

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Christophe FERRE, PhD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 2, 2017
• Study Start: October 11, 2017
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: April 12, 2023

Record last verified: 2018-09

Locations

FR (5)