Multiple SclerosisNCT03787446
PET Study in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University of British Columbia at 1 site in Canada.
Trial summary
While both conventional and advanced MRI techniques offer important insights into MS pathophysiology, important aspects of this inflammatory disorder are undetectable with existing MRI technology. 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
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 26 Mar 2019to Sep 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 3 untreated RRMS, 3 untreated PPMS and 3 healthy controls
Who may be able to join
- Subjects diagnosed with Multiple Sclerosis according to the 2010 McDonald criteria or otherwise in the opinion of the investigator (including relapsing-remitting and primary-progressive).
- Aged 18 to 60 years.
- Mixed affinity binder according to rs6971 TSPO polymorphism1.
- Creatinine clearance over 60 mL/min*). * Blood result valid up to 3 months prior to the MRI scan.
Who cannot join
- Low and high affinity binders according to rs6971 TSPO polymorphism
- Subject pregnant or breastfeeding.
- Subjects with a Body Mass Index (BMI) >35kg/m³.
- Hospitalization within 1 month of screening visit.
- Medical history or current heart failure
- Medical history or current pulmonary failure
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- Current or Historical Drug or alcohol abuse in the opinion of the investigator.
- Regular use of anti-inflammatory agents (more than once a week use of aspirin, NSAIDS, Steroids, immunomodulating drugs), unless patient is able to washout from anti-inflammatory drugs 2 weeks prior to PBR PET scan.
- Neurological disorder other than MS, including Brain Trauma, stroke, Parkinson disease, Alzheimer disease, encephalitis.
- Subjects with a history of radiation treatment or other high amounts of radiation exposure in the opinion of the investigator.
- Subjects with a history of metastatic cancer including solid tumors and hematological malignancies, except basal cell, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix or the uterus that have been excised with clear margins.
- Inability to tolerate lying supine for the duration of the MRI and PET scan.
- Claustrophobia.
- Current use of MS drugs as described by the list of prohibited medications.
- Exclusion specific to MRI (All MRI specific criteria is subject to conditions posed by the MRI technologist or radiologist):
- Known or suspected piece of metal in eye(s)
- Irremovable piercing or recent tattoos in the last 6 weeks
- Cardiac pacemakers, wires or defibrillator
- Artificial heart valve
- Brain aneurysm clip
- Electrical stimulator for nerves or bones
- Deep brain stimulator
- Implanted drug infusion pump
- Coil, catheter, or filter in any blood vessel
- Orthopedic hardware (artificial joint, plate, screws) inserted within the last 6 weeks
- Surgery within the last 6 weeks
- Harrington rod for scoliosis
- Other metallic prosthesis
- Any metal fragments, Shrapnel, bullets, or metal prosthesis
- Irremovable dentures, braces or retainer(s)
- IUDs containing metal
- Previous surgery of the brain, eyes, ears, breast, chest, heart, or spine in the opinion of the investigator and MRI technician(s)
- Medical history of Macular degeneration
- Degenerative and/or symptomatic Retinopathy
- Medical history of Glaucoma
- Medical history of Amblyopia with vision loss
- Medical history of Diabetes
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
UBC MS & NMO Clinical Trials Group
Vancouver, British Columbia, V6T1Z3
Janice Jong, 604-827-1892, janice.jong@ubc.ca
Robert L Carruthers, MD, FRCPS
About this study
Official title: Positron Emission Tomography (PET) Imaging Study in Relapsing-Remitting and Primary-Progressive Multiple Sclerosis (MS): Correlations With Advanced MRI in MS
While both conventional and advanced MRI techniques offer important insights into MS pathophysiology, important aspects of this inflammatory disorder are undetectable with existing MRI technology. In Multiple Sclerosis (MS), there is growing interest in PET as an imaging modality that can increase the investigator's understanding of the disease processes and may add to an understanding of MS phenotype, particularly when combined with advanced MRI techniques such as myelin water imaging.
Read the detailed description
This is an exploratory study. PBR28 PET scan is new, promising and exploratory endpoints in MS clinical trials, making sample size estimation difficult.
A separate pre-screening consent form will be issued for the TSPO rs6971 polymorphism and eGFR blood samples, a separate pre-screening step. Eligible participants, according to their TSPO rs6971 polymorphism will be presented a separate study consent form to continue into the clinical trial.
Study Assessments include 1 PET scan, 1 MRI scan, OCT, EDSS exam, physical exam, cognitive questionnaires, etc.
- 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 | 3 Primary Progressive MS patients on no disease modifying therapy and 3 Relapsing-Remitting MS patients on no disease modifying therapy | |
| Healthy Controls (HC) | 3 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
To show an increase in 11C-PBR28 binding in all sub-types of MS compared to healthy controls.
Measured: January 2020
Secondary outcomes (3)
Myelin Water Imaging by MRI
To quantitatively measure the brain levels of water located within myelin
Measured: January 2020
Optical Coherence Tomography
To correlate brain levels of inflammation measured by 11C-PBR28 with Retinal Nerve Fiber Layer (RNFL) thickness on Optical Coherence Tomography (OCT).
Measured: January 2020
MS Spectroscopy
To correlate brain levels of inflammation and myelin measured by PET with cognitive dysfunction in MS patients.
Measured: January 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start26 Mar 2019
- Primary completionMar 2020 (estimated)
- Study completionSep 2020 (estimated)
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
- Cross-sectional
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Principal investigator, Robert Carruthers, University of British Columbia
- Investigators
- Robert L Carruthers, MD, Principal investigator, MS Clinical Trials Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787446
- Sponsor's protocol ID
- H18-02393
- Status last verified
- Apr 2019
- First submitted
- 19 Dec 2018
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography (PET) Imaging Study in Relapsing-Remitting and Primary-Progressive Multiple Sclerosis (MS): Correlations With Advanced MRI in MS
- ClinicalTrials.gov ID
- NCT03787446
- Acronym / sponsor ID
- H18-02393
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 26 Dec 2018 (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.
While both conventional and advanced MRI techniques offer important insights into MS pathophysiology, important aspects of this inflammatory disorder are undetectable with existing MRI technology. In Multiple Sclerosis (MS), there is growing interest in PET as an imaging modality that can increase the investigator's understanding of the disease processes and may add to an understanding of MS phenotype, particularly when combined with advanced MRI techniques such as myelin water imaging.
Detailed description
This is an exploratory study. PBR28 PET scan is new, promising and exploratory endpoints in MS clinical trials, making sample size estimation difficult.
A separate pre-screening consent form will be issued for the TSPO rs6971 polymorphism and eGFR blood samples, a separate pre-screening step. Eligible participants, according to their TSPO rs6971 polymorphism will be presented a separate study consent form to continue into the clinical trial.
Study Assessments include 1 PET scan, 1 MRI scan, OCT, EDSS exam, physical exam, cognitive questionnaires, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis (MS) patients | – | –3 Primary Progressive MS patients on no disease modifying therapy and 3 Relapsing-Remitting MS patients on no disease modifying therapy |
| Healthy Controls (HC) | – | –3 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
- 3 untreated RRMS, 3 untreated PPMS and 3 healthy controls
Key inclusion criteria (4 listed)
- Subjects diagnosed with Multiple Sclerosis according to the 2010 McDonald criteria or otherwise in the opinion of the investigator (including relapsing-remitting and primary-progressive).
- Aged 18 to 60 years.
- Mixed affinity binder according to rs6971 TSPO polymorphism1.
- Creatinine clearance over 60 mL/min*). * Blood result valid up to 3 months prior to the MRI scan.
Key exclusion criteria (37 listed)
- Low and high affinity binders according to rs6971 TSPO polymorphism
- Subject pregnant or breastfeeding.
- Subjects with a Body Mass Index (BMI) >35kg/m³.
- Hospitalization within 1 month of screening visit.
- Medical history or current heart failure
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: January 2020
To show an increase in 11C-PBR28 binding in all sub-types of MS compared to healthy controls.
3 secondary outcomes
Myelin Water Imaging by MRI
Time frame: January 2020
Optical Coherence Tomography
Time frame: January 2020
MS Spectroscopy
Time frame: January 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Robert L Carruthers, MD principal investigator
MS Clinical Trials Group
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 4 inclusion and 37 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: status not confirmed, as of the sponsor's last update on 22 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janice Jong (604-827-1892, janice.jong@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole Brain PBR28 binding (time frame: January 2020). 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 22 Apr 2019.