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Completed

NCT Number: NCT03205280

Clinical Decision Support System (CADIMS) for MS Diagnostic

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Bretagne Sud, Lorient, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: At the end of the enrollment

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Association Neuro-Bretagne
  • Groupement de Coopération Sanitaire e-Santé Bretagne
  • Institut National de Recherche en Informatique et en Automatique
  • Institut de Recherche Technologique b<>com

Registry information

Official study title

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

Acronym: POCADIMS

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 2, 2017
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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