Evaluation of an Automatic Segmentation Software (Pixyl.Neuro) to Track Lesions in Multiple Sclerosis Patients Via Cerebral MRI

NCT03438357 | Completed

• 1 other identifier: IDIL/2017/ET-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Using an automatic software tool, Pixyl.Neuro, to conduct a retrospective analysis (detection of lesions + segmentation of images + tracking over time) of cerebral MRI images acquired during a prospective study of patients presenting with clinically isolated syndrome, and comparing the results against manual analysis.

Conditions

Multiple Sclerosis; Clinically Isolated Syndrome

Outcome Measures

Primary Outcomes (1)

• Lesions detected by Pixyl.Neuro software that were missed by manual analysis of MRI images follow-up images compared to reference image (new T2 lesions, enlarging T2 lesions, new T1 gadolinium lesions)

  % cases

  baseline until follow-up (maximum 2 years)

Secondary Outcomes (3)

• Inter-reader reproducibility

  baseline until follow-up (maximum 2 years)

• Software versus manual analysis reproducibility for same reader

  baseline until follow-up (maximum 2 years)

• Classification of discordances

  baseline until follow-up (maximum 2 years)

Study Arms (1)

Patients with multiple sclerosis

Other: Analysis of cerebral MRI with automatic segmentation software

Interventions

Analysis of cerebral MRI with automatic segmentation software OTHER

Pixyl.Neuro software versus manual analysis of lesions

Patients with multiple sclerosis

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subset of patient data collected for the project D-Lay-MS: NCT01817166

You may qualify if:

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 24 months of follow-up
• The patient has had a classic CIS with the past 90 days
• Reference cerebro-medullary MRI scheduled within the 90 days after the beginning of symptoms
• With MRI (cerebro ± medullary) showing demyelination according to spatial spread criteria by Swanton (2006):
• At least 1 lesion in at least 2 of the 4 following territories: (1) Peri-ventricular; (2) Juxta-cortical; (3) Sub-tentorial; (4) Medullary
• No other suspected pathology
• Women of childbearing potential must use very effective contraception for the duration of the study. A very effective contraceptive method is defined as a method resulting in a low failure rate (that is to say less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, IUDs, sexual abstinence, or partner with a vasectomy.
• Randomisation stratification criteria:
• The patient can also also meet the temporal dissemination criteria defined according to McDonald criteria 2010 (Polman et al., 2011), because this condition is currently not sufficient for prescribing a background treatment: Simultaneous presence of at least one asymptomatic lesion taking on contrast and at least one asymptomatic lesion not taking on contrast after injection of gadolinium

You may not qualify if:

• The patient is participating in another study other than D-Lay-MS: NCT01817166 (this criteria does not apply to the POLAR study (RCB 2011-A01269-32); patients included in this study may simultaneously participate in the POLAR study)
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient, or breastfeeding
• Major medical or psychiatric illness that, according to the investigator, would result in the patient running an unnecessary risk or that could affect compliance with the study protocol
• Vitamin D insufficiency linked to currently active digestive or more general diseases (celiac disease, inflammatory bowel disease, intestinal bypass, short bowel syndrome, cirrhosis, nephrotic syndrome, hyperthyroidism, rickets, hypoparathyroidism, cancer, granulomatous diseases and lymphomas)
• Moderate or severe renal insufficiency (creatinine clearance less than 60 ml / min)
• Epilepsy not adequately controlled by treatment
• Any illness requiring chronic treatment with corticosteroids
• Patient with osteoporosis or history of osteopenia
• Pathology requiring calcium intakes greater than 1 gram per day
• Current or past history of hypercalcemia
• Medications that affect the metabolism of vitamin D other than corticosteroids; e.g. anticonvulsants \[phenobarbital, primidone, phenytoin\] rifampicin, isoniazid, ketoconazole, 5-FU and leucovorin, thiazide diuretics.
• Situations accompanied by increased vulnerability to hypercalcemia, e.g. arrhythmia or known heart disease, treatment with digitalis, and subjects with nephrolithiasis.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Roche Pharma AG: collaborator

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eric Thouvenot

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 19, 2018
• Study Start: January 2, 2019
• Primary Completion: July 6, 2022
• Study Completion: July 6, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

FR (1)