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Clinical Decision Support System (CADIMS) for MS Diagnostic

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03205280
Acronym
POCADIMS
Enrollment
200
Registered
2017-07-02
Start date
2017-10-11
Completion date
2022-12-07
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, Relapsing-Remitting, Computer-Assisted Diagnosis, MRI, Diagnosis, Treatment Efficacy

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.

Interventions

None listed

Sponsors

Association Neuro-Bretagne
CollaboratorUNKNOWN
Institut National de Recherche en Informatique et en Automatique
CollaboratorOTHER
Groupement de Coopération Sanitaire e-Santé Bretagne
CollaboratorUNKNOWN
Institut de Recherche Technologique b<>com
CollaboratorUNKNOWN
Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 consensusAt the end of the enrollment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026