Multiple SclerosisNCT04145284
Quantitative Magnetic Resonance Imaging (MRI) Sub-Study of MS PATHS
An observational study of Multiple Sclerosis, run by Biogen at 2 sites in 2 countries.
Trial summary
The primary objective is to assess the performance of a new magnetic resonance imaging (MRI) metrics software prototype when used in radiological practice in multiple sclerosis (MS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 6 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Apr 2019to 30 Apr 2020
- 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: The study population is the cohort of radiologists.
Who may be able to join
- Board-certified neuroradiologists or experienced neuroradiology fellows.
- Employed at a participating MS PATHS institution.
- At least 3 years of experience in interpreting brain MRI scans of MS participants.
Who cannot join
- Inability to comply with sub-study procedures.
- Other unspecified reasons that, in the opinion of Biogen or the MS PATHS Radiology Lead at the institution, make the radiologist unsuitable for participation.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Performance and Feasibility of Quantitative MRI Metrics in Routine Radiology Practice: A Sub-Study of MS PATHS
The primary objective is to assess the performance of a new magnetic resonance imaging (MRI) metrics software prototype when used in radiological practice in multiple sclerosis (MS).
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologist Assessment of the Performance of the MS MRI Metrics Software Prototype by the Number of Approve or Reject Decision
MRIs from participants will be analyzed by the prototype. The radiologist will view the brain segmentation results and the new or enlarging T2 lesion detection results. The radiologist will either "Approve" or "Reject" the results.
Measured: Baseline up to 6 weeks
Radiologist Assessment of the Performance of the MS MRI Metrics Software Prototype by the Number of False-Positive and False-Negative Lesions
MRIs from participants will be analyzed by the prototype. The radiologist will view the new or enlarging T2 lesions to determine false-positive or false-negative results.
Measured: Baseline up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start30 Apr 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145284
- Sponsor's protocol ID
- 888MS007
- Status last verified
- Mar 2021
- First submitted
- 29 Oct 2019
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Feasibility of Quantitative MRI Metrics in Routine Radiology Practice: A Sub-Study of MS PATHS
- ClinicalTrials.gov ID
- NCT04145284
- Acronym / sponsor ID
- 888MS007
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 30 Oct 2019 (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.
The primary objective is to assess the performance of a new magnetic resonance imaging (MRI) metrics software prototype when used in radiological practice in multiple sclerosis (MS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is the cohort of radiologists.
Key inclusion criteria (3 listed)
- Board-certified neuroradiologists or experienced neuroradiology fellows.
- Employed at a participating MS PATHS institution.
- At least 3 years of experience in interpreting brain MRI scans of MS participants.
Key exclusion criteria (2 listed)
- Inability to comply with sub-study procedures.
- Other unspecified reasons that, in the opinion of Biogen or the MS PATHS Radiology Lead at the institution, make the radiologist unsuitable for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiologist Assessment of the Performance of the MS MRI Metrics Software Prototype by the Number of Approve or Reject Decision
Time frame: Baseline up to 6 weeks
MRIs from participants will be analyzed by the prototype. The radiologist will view the brain segmentation results and the new or enlarging T2 lesion detection results. The radiologist will either "Approve" or "Reject" the results.
Radiologist Assessment of the Performance of the MS MRI Metrics Software Prototype by the Number of False-Positive and False-Negative Lesions
Time frame: Baseline up to 6 weeks
MRIs from participants will be analyzed by the prototype. The radiologist will view the new or enlarging T2 lesions to determine false-positive or false-negative results.
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 24 Mar 2021.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
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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.
Medical Director study director
Biogen
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Biogen at 2 sites in 2 countries.
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 3 inclusion and 2 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 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. 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?
Radiologist Assessment of the Performance of the MS MRI Metrics Software Prototype by the Number of Approve or Reject Decision (time frame: Baseline up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2021.