Multiple Sclerosis)NCT04369898
Combined Sensitivity and Specificity of Cortical Lesions and Central Vein Sign for MS Diagnosis and Differential Diagnosis
An observational study of Multiple Sclerosis), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study investigates the specificity/sensitivity of the combined presence of cortical lesions (CLs)/leuco-cortical lesions (LCLs) and central veins sign (CVs) for multiple sclerosis (MS) diagnosis and differential diagnosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis)
- What is being tested?
- Image analysis/ Central vein detection and Image analysis/ Automatic cortical lesion detection
- How many people
- 1,051 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2010to Sep 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: MRI and clinical coded data will be collected from some of the European centers that belong to the MAGNIMS consortium (Oxord University, University College London, University Hospital Vall d'Hebron (Barcelona), Verona University) as well as from Basel University hospital. MAGNIMS members and associate centers have a common data-sharing agreement (enclosed). MAGNIMS is an independent European network of academics that share a common interest in the study of multiple sclerosis (MS) using magnetic resonance imaging (MRI). MRI data must have been collected at 3T between 1990 and 2020.
Who may be able to join
- Clinical and MRI data of patients with MS or MS mimics (migraine, vasculitis, diabetes, neuromyelitis optica spectrum disorder)
- MRI data must have been collected at 3T between 1990 and 2020 and must include T1 w, T2 w, T2-star based sequence (CVs detection) and DIR/PSIR/MP2RAGE (eventually also high spatial resolution MPRAGE) for cortical lesion detection
Who cannot join
- Unavailability of institutional informed consent
- Unclear diagnosis
- Other neurological or psychiatric diseases.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Translational Imaging in Neurology, University Hospital Basel
Basel, 4031
About this study
Official title: A Multi-centric Study of the Combined Sensitivity and Specificity of Cortical Lesions and Central Vein Sign for MS Diagnosis and Differential Diagnosis
This study investigates the specificity/sensitivity of the combined presence of cortical lesions (CLs)/leuco-cortical lesions (LCLs) and central veins sign (CVs) for multiple sclerosis (MS) diagnosis and differential diagnosis.
Read the detailed description
CLs and LCLs may be detected at 3 Tesla (T) MRI by using dedicated sequences. 3D Double inversion recovery (DIR), Phase-Sensitive Inversion Recovery (PSIR), Magnetization Prepared - RApid Gradient Echo (MPRAGE) and Magnetization Prepared - 2- RApid Gradient Echo (MP2RAGE) have all shown variable sensitivity to CLs and LCLs. The central vein sign (CVS, i.e. the detection of a central vessel in a focal lesion) has been recently proposed as a biomarker for distinguishing between MS and not and not MS. Both the presence of CL and CVs brings high sensitivity and specificity in distinguishing MS from not MS patients; whether their combination achieves higher sensitivity and specificity to MS diagnosis and differential diagnosis is to date not know. This study investigates the specificity/sensitivity of the combined presence of cortical lesions (CLs)/leuco-cortical lesions (LCLs) and central veins sign (CVs) for multiple sclerosis (MS) diagnosis and differential diagnosis.
- Conditions
- Multiple Sclerosis)
- Being tested
- Image analysis/ Central vein detection, Image analysis/ Automatic cortical lesion detection
- Keywords
- cortical lesions, leuco-cortical lesions, central vein sign
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image analysis/ Central vein detectionOther
Image analysis/ Central vein detection will be performed using a fully automated approach based on an ensemble of 3D convolutional neural Networks. The method is applied to T1w, T2w and T2*w data . Results will be manually reviewed by 2 experts in CVs detection. MRI data must have been collected at 3 Tesla (3T) between 1990 and 2020 and must include T1 w, T2 w, T2-star based sequence (CVs detection).
Image analysis/ Automatic cortical lesion detectionOther
Image analysis/ Automatic cortical lesion detection will be performed by using a convolutional neural network-based method. MRI data must have been collected at 3T between 1990 and 2020 and must include Double inversion recovery (DIR)/Phase-Sensitive Inversion Recovery (PSIR)/Magnetization Prepared - 2- RApid Gradient Echo Gradient Echo (MP2RAGE) (eventually also high spatial resolution Magnetization Prepared - RApid Gradient Echo (MPRAGE)) for cortical lesion detection.
What is being measured
The primary outcome is the main question the study is designed to answer.
differentiation between patients with MS and clinically isolated syndrome and patients without MS (specificity)
differentiation between patients with MS and clinically isolated syndrome and patients without MS by analyzing the combination of the presence of CL/LCLs and CVs as compared to the sensitivity/specificity achieved by either CL/LCLs or CVs (sensitivity)
Measured: at Baseline
differentiation between patients with MS and clinically isolated syndrome and patients without MS ((specificity)
differentiation between patients with MS and clinically isolated syndrome and patients without MS by analyzing the combination of the presence of CL/LCLs and CVs as compared to the sensitivity/specificity achieved by either CL/LCLs or CVs (sensitivity)
Measured: at Baseline
specificity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
specificity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
Measured: at Baseline
sensitivity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
sensitivity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
Measured: at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 Jun 2010
- Primary completionDec 2022
- Study completionSep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,051 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina Granziera, Prof., Principal investigator, Translational Imaging in Neurology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369898
- Sponsor's protocol ID
- 2020-00765; me20Granziera
- Status last verified
- Jan 2024
- First submitted
- 27 Apr 2020
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
La Rosa F, Wynen M, Al-Louzi O, Beck ES, Huelnhagen T, Maggi P, Thiran JP, Kober T, Shinohara RT, Sati P, Reich DS, Granziera C, Absinta M, Bach Cuadra M. Cortical lesions, central vein sign, and paramagnetic rim lesions in multiple sclerosis: Emerging machine learning techniques and future avenues. Neuroimage Clin. 2022;36:103205. doi: 10.1016/j.nicl.2022.103205. Epub 2022 Sep 24.
PubMed 36201950
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centric Study of the Combined Sensitivity and Specificity of Cortical Lesions and Central Vein Sign for MS Diagnosis and Differential Diagnosis
- ClinicalTrials.gov ID
- NCT04369898
- Acronym / sponsor ID
- 2020-00765; me20Granziera
- Conditions
- Multiple Sclerosis)
- Keywords
- cortical lesions, leuco-cortical lesions, central vein sign
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,051 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Sep 2023 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the specificity/sensitivity of the combined presence of cortical lesions (CLs)/leuco-cortical lesions (LCLs) and central veins sign (CVs) for multiple sclerosis (MS) diagnosis and differential diagnosis.
Detailed description
CLs and LCLs may be detected at 3 Tesla (T) MRI by using dedicated sequences. 3D Double inversion recovery (DIR), Phase-Sensitive Inversion Recovery (PSIR), Magnetization Prepared - RApid Gradient Echo (MPRAGE) and Magnetization Prepared - 2- RApid Gradient Echo (MP2RAGE) have all shown variable sensitivity to CLs and LCLs. The central vein sign (CVS, i.e. the detection of a central vessel in a focal lesion) has been recently proposed as a biomarker for distinguishing between MS and not and not MS. Both the presence of CL and CVs brings high sensitivity and specificity in distinguishing MS from not MS patients; whether their combination achieves higher sensitivity and specificity to MS diagnosis and differential diagnosis is to date not know. This study investigates the specificity/sensitivity of the combined presence of cortical lesions (CLs)/leuco-cortical lesions (LCLs) and central veins sign (CVs) for multiple sclerosis (MS) diagnosis and differential diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MRI and clinical coded data will be collected from some of the European centers that belong to the MAGNIMS consortium (Oxord University, University College London, University Hospital Vall d'Hebron (Barcelona), Verona University) as well as from Basel University hospital. MAGNIMS members and associate centers have a common data-sharing agreement (enclosed). MAGNIMS is an independent European network of academics that share a common interest in the study of multiple sclerosis (MS) using magnetic resonance imaging (MRI). MRI data must have been collected at 3T between 1990 and 2020.
Key inclusion criteria (2 listed)
- Clinical and MRI data of patients with MS or MS mimics (migraine, vasculitis, diabetes, neuromyelitis optica spectrum disorder)
- MRI data must have been collected at 3T between 1990 and 2020 and must include T1 w, T2 w, T2-star based sequence (CVs detection) and DIR/PSIR/MP2RAGE (eventually also high spatial resolution MPRAGE) for cortical lesion detection
Key exclusion criteria (3 listed)
- Unavailability of institutional informed consent
- Unclear diagnosis
- Other neurological or psychiatric diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image analysis/ Central vein detectionImage analysis/ Central vein detection will be performed using a fully automated approach based on an ensemble of 3D convolutional neural Networks. The method is applied to T1w, T2w and T2*w data . Results will be manually reviewed by 2 experts in CVs detection. MRI data must have been collected at 3 Tesla (3T) between 1990 and 2020 and must include T1 w, T2 w, T2-star based sequence (CVs detection). | Other | – |
| Image analysis/ Automatic cortical lesion detectionImage analysis/ Automatic cortical lesion detection will be performed by using a convolutional neural network-based method. MRI data must have been collected at 3T between 1990 and 2020 and must include Double inversion recovery (DIR)/Phase-Sensitive Inversion Recovery (PSIR)/Magnetization Prepared - 2- RApid Gradient Echo Gradient Echo (MP2RAGE) (eventually also high spatial resolution Magnetization Prepared - RApid Gradient Echo (MPRAGE)) for cortical lesion detection. | Other | – |
Primary outcome
differentiation between patients with MS and clinically isolated syndrome and patients without MS (specificity)
Time frame: at Baseline
differentiation between patients with MS and clinically isolated syndrome and patients without MS by analyzing the combination of the presence of CL/LCLs and CVs as compared to the sensitivity/specificity achieved by either CL/LCLs or CVs (sensitivity)
differentiation between patients with MS and clinically isolated syndrome and patients without MS ((specificity)
Time frame: at Baseline
differentiation between patients with MS and clinically isolated syndrome and patients without MS by analyzing the combination of the presence of CL/LCLs and CVs as compared to the sensitivity/specificity achieved by either CL/LCLs or CVs (sensitivity)
specificity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
Time frame: at Baseline
specificity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
sensitivity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
Time frame: at Baseline
sensitivity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Results publication: PubMed 36201950La Rosa F, Wynen M, Al-Louzi O, Beck ES, Huelnhagen T, Maggi P, Thiran JP, Kober T, Shinohara RT, Sati P, Reich DS, Granziera C, Absinta M, Bach Cuadra M. Cortical lesions, central vein sign, and paramagnetic rim lesions in multiple sclerosis: Emerging machine learning techniques and future avenues. Neuroimage Clin. 2022;36:103205. doi: 10.1016/j.nicl.2022.103205. Epub 2022 Sep 24.
- Cortical lesions, central vein sign, and paramagnetic rim lesions in multiple sclerosis: Emerging machine learning techniques and future avenuesLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Granziera, Prof. principal investigator
Translational Imaging in Neurology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 inclusion and 3 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 22 Jan 2024. 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 Switzerland. 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?
differentiation between patients with MS and clinically isolated syndrome and patients without MS (specificity) (time frame: at Baseline). The study lists 4 primary outcomes in all. 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 NCT04369898, which also lists 1 linked publication.
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 22 Jan 2024.