Multiple SclerosisNCT02869360
Correlation Between PET and Advanced MRI in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University of British Columbia at 1 site in Canada.
Trial summary
Traditional Magnetic Resonance Imaging (MRI) in Multiple Sclerosis (MS) has enabled clinicians to measure disease activity but there are inherent limitations. Clinical/radiographic dissociation can be seen in some patients and the abnormalities are not specific. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to 2 Oct 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 4 untreated RRMS, 4 untreated SPMS, 4 untreated PPMS patients, 4 healthy controls and 4 GA 40mg TIW
Who may be able to join
- Diagnosed with Multiple Sclerosis according to the 2011 McDonald criteria.
- Aged 18 to 60
- High or mixed affinity binder to rs6971 TSPO polymorphism
Who cannot join
- Pregnant or breastfeeding
- Suffering from an unstable medical condition
- Have a neurological or ocular disorder other than MS
- Any contra-indications to MRI
Trial locations and contacts
1 site in 1 country.
Canada1 site
MS Clinical Trials Group - UBC
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: Pilot Study of Positron Emission Tomography (PET) Imaging: Correlations With Advanced Magnetic Resonance Imaging in Multiple Sclerosis
Traditional Magnetic Resonance Imaging (MRI) in Multiple Sclerosis (MS) has enabled clinicians to measure disease activity but there are inherent limitations. Clinical/radiographic dissociation can be seen in some patients and the abnormalities are not specific.
This pilot study is an opportunity to determine the relationship between quantitative advanced MRI measures and OCT with PET measurements of microglial activation and myelin health.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis (MS) patients | 4 Secondary Progressive MS patients on no disease modifying therapy 4 Primary Progressive MS patients on no disease modifying therapy 4 Relapsing-Remitting MS patients on no disease modifying therapy 4 Relapsing-Remitting MS patients on Glatiramer Acetate 40 mg three times a week | |
| Healthy Controls | 4 Healthy volunteers aged between 18-60 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole Brain PBR28 binding
Measured: Baseline
Secondary outcomes (4)
Lesional PiB binding
Measured: Baseline
Myelin Water Imaging
Measured: Baseline
MR Spectroscopy (Total NAA, NAA/Cr, mI)
Measured: Baseline
Optical Coherence Tomography (RNFL thickness)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startOct 2016
- Primary completion2 Oct 2019
- Study completion2 Oct 2019
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 University of British ColumbiaThe 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Principal investigator, Philippe Beauchemin, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869360
- Sponsor's protocol ID
- CNS-2016-293
- Status last verified
- Oct 2019
- First submitted
- 12 Aug 2016
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Positron Emission Tomography (PET) Imaging: Correlations With Advanced Magnetic Resonance Imaging in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02869360
- Acronym / sponsor ID
- CNS-2016-293
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- Oct 2016
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 2 Oct 2019 (actual)
- First posted
- 16 Aug 2016 (estimated)
- 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.
Traditional Magnetic Resonance Imaging (MRI) in Multiple Sclerosis (MS) has enabled clinicians to measure disease activity but there are inherent limitations. Clinical/radiographic dissociation can be seen in some patients and the abnormalities are not specific.
This pilot study is an opportunity to determine the relationship between quantitative advanced MRI measures and OCT with PET measurements of microglial activation and myelin health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis (MS) patients | – | –4 Secondary Progressive MS patients on no disease modifying therapy 4 Primary Progressive MS patients on no disease modifying therapy 4 Relapsing-Remitting MS patients on no disease modifying therapy 4 Relapsing-Remitting MS patients on Glatiramer Acetate 40 mg three times a week |
| Healthy Controls | – | –4 Healthy volunteers aged between 18-60 years of age |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 4 untreated RRMS, 4 untreated SPMS, 4 untreated PPMS patients, 4 healthy controls and 4 GA 40mg TIW
Key inclusion criteria (3 listed)
- Diagnosed with Multiple Sclerosis according to the 2011 McDonald criteria.
- Aged 18 to 60
- High or mixed affinity binder to rs6971 TSPO polymorphism
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- Suffering from an unstable medical condition
- Have a neurological or ocular disorder other than MS
- Any contra-indications to MRI
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
Whole Brain PBR28 binding
Time frame: Baseline
4 secondary outcomes
Lesional PiB binding
Time frame: Baseline
Myelin Water Imaging
Time frame: Baseline
MR Spectroscopy (Total NAA, NAA/Cr, mI)
Time frame: Baseline
Optical Coherence Tomography (RNFL thickness)
Time frame: Baseline
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 3 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 of British Columbia at 1 site in Canada.
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 4 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 3 Oct 2019. 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 Canada. 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?
Whole Brain PBR28 binding (time frame: Baseline). 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 3 Oct 2019.