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Multiple SclerosisPIXCISNCT03438357

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

An observational study of Multiple Sclerosis and Clinically Isolated Syndrome, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 56 years
What is being tested?
Analysis of cerebral MRI with automatic segmentation software
How many people
200 participants
Where
1 siteFrance
Study dates
2 Jan 2019to 6 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 56 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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):
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  • 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
  • Vitamin D level in blood less than 100 nmol / l at the pre-inclusion visit
  • 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

Who cannot join

  • 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 in an exclusion period determined by a previous 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
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  • 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.
  • Contraindications to vitamin D3 as mentioned in the documentation for UVEDOSE
  • Known hypersensitivity to gadolinium and / or known inability to undergo an MRI (pacemaker, osteosynthesis material, intraocular metal splinter, etc ....).
  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Nimes

    Nîmes, 30029

Other trials in France

About this study

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.

Being tested
Analysis of cerebral MRI with automatic segmentation software
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Analysis of cerebral MRI with automatic segmentation softwareOther

    Pixyl.Neuro software versus manual analysis of lesions

Study groups in NCT03438357
Study groupRoleWhat they receive
Patients with multiple sclerosisNot described
Receives: Other: Analysis of cerebral MRI with automatic segmentation software

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline until follow-up (maximum 2 years)

Secondary outcomes (3)

  1. Inter-reader reproducibility

    DICE similarity coefficient between readers

    Measured: baseline until follow-up (maximum 2 years)

  2. Software versus manual analysis reproducibility for same reader

    DICE similarity coefficient between software result and manual result

    Measured: baseline until follow-up (maximum 2 years)

  3. Classification of discordances

    Specific description of missed lesions according to technology at fault

    Measured: baseline until follow-up (maximum 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start2 Jan 2019
  3. Primary completion6 Jul 2022
  4. Study completion6 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03438357
Sponsor's protocol ID
IDIL/2017/ET-01
Acronym
PIXCIS
Status last verified
Feb 2023
First submitted
2 Feb 2018
Last updated
8 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis and Clinically Isolated Syndrome, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: baseline until follow-up (maximum 2 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03438357.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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