Multiple SclerosisSELPETNCT06460077
Exploring Pathology Related to Slowly Expanding Lesions Using Advanced Imaging
An observational study of Multiple Sclerosis, run by Turku University Hospital at 1 site in Finland.
Trial summary
This is an open, follow-up study to compare the performance of three critical imaging methods to detect chronic active lesions in Multiple Sclerosis (MS) in vivo. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 15 participants
- Where
- 1 siteFinland
- Study dates
- 3 Oct 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 52 MS patients with simultaneous QSM-MRI and TSPO-PET and with available longitudinal brain MRI images (minimum 1 year) have been identified. With an average detection frequency of >= 1 SEL in 70% of MS patients, there will be sufficient imaging material for successful conduct of the study.
Who may be able to join
- Signing the informed consent form
- MS diagnosis in accordance with McDonald 2017 criteria
- Available longitudinal brain MR images (minimum 1 year)
- Simultaneous QSM MRI sequence and TSPO-PET
- Lesions with iron rim/s
Who cannot join
- Patients with other neurodegenerative disease than MS
- Patients with other autoimmune disease than MS
- Patients with other significant or malignant underlying disease of any other organ system
- Patients that are pregnant or breast-feeding
- Corticosteroid treatment within 4 weeks of imaging
- Patients with significant abnormal findings other than MS in the screening MRI
Show all 10Show fewer
- Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
- Contraindication to PET scan investigations
- Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study
- Intolerance to previous PET scans; i.e. previous hypersensitivity reactions to any PET ligand or imaging agent or failure to participate in and comply with previous PET scans
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This is an open, follow-up study to compare the performance of three critical imaging methods to detect chronic active lesions in Multiple Sclerosis (MS) in vivo.
Read the detailed description
Smoldering inflammation is recognized as a critical contributor to MS progression-related central nervous system (CNS) damage. Activated microglia and macrophages particularly at chronic lesion edge are believed to promote lesion growth. Reversing their harmful activity may prove to be an efficient way to halt progression independent of relapses in MS.
These smoldering, or chronic active lesions can be detected in vivo using advanced imaging techniques. 1) Specific algorithms can be used to identify lesion growth, with a hypothesis that the slowly evolving lesions (SEL) are the ones harboring a rim of activated microglial cells, which contribute to damage in the surrounding tissue, and lesion growth. 2) Lesions partially or entirely surrounded by rims of increased tissue intensity on QSM-MRI (quantitative susceptibility mapping) sequences are considered as iron rim lesions, with iron-containing proinflammatory microglia/macrophages at the lesion edge. 3) In addition, 18 kDa translocator protein-positron emission tomography (TSPO-PET) imaging can be used to identify chronic active lesions based on TSPO-expression by activated innate immune cells, and their gathering at the edges of chronic active lesions. The TSPO-PET analysis of chronic active lesions can be semi-automated, and the specific radioligand binding at the chronic active lesion edge can be quantitated, which enhances the sensitivity of this method.
Despite existing preliminary data demonstrating increased QSM signal TSPO-positive lesions, it is yet to be demonstrated how these three imaging methods perform in identifying chronic active lesions when compared to each other at larger scale.
- 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 |
|---|---|---|
| Patients with Multiple Sclerosis | Patients who have previously participated in PET-imaging studies and from whom slowly expanding lesions as well as TSPO-rim-positive lesions and iron rims at the edge of lesions are found |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of lesions
The number of lesions identified using each respective method
Measured: 18 months, 36 months
Co-localization of lesions
Potential co-localization of the RIM+ lesions identified using the various methods.
Measured: 18 months, 36 months
Secondary outcomes (4)
Correlation of PET imaging and clinical variables
Imaging variables from PET imaging correlated with clinical status of the patient evaluated with Expanded Disability Status scale (EDSS). EDSS describes the disability level and ranges from 0 to 10, where 0 means no disability due to MS and 10 means death due MS.
Measured: 18 months, 36 months
Correlation of magnetic resonance imaging and clinical variables
Imaging variables from MR imaging correlated with clinical status of the patient evaluated with Expanded Disability Status scale (EDSS). EDSS describes the disability level and ranges from 0 to 10, where 0 means no disability due to MS and 10 means death due MS.
Measured: 18 months, 36 months
Correlation of quality of life questionnaires and clinical variables
Correlation of quality of life questionnaires and clinical status of the patient evaluated with Expanded Disability Status scale (EDSS). EDSS describes the disability level and ranges from 0 to 10, where 0 means no disability due to MS and 10 means death due MS.
Measured: 18 months, 36 months
Correlation of neuropsychological evaluation and clinical variables
Correlation of neuropsychological evaluation and clinical status of the patient evaluated with Expanded Disability Status scale (EDSS). EDSS describes the disability level and ranges from 0 to 10, where 0 means no disability due to MS and 10 means death due MS.
Measured: 18 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start3 Oct 2024
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (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 Turku University HospitalThe 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Laura Airas, MD,Professor, Principal investigator, Turku University Hospital, division of clinical neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460077
- Sponsor's protocol ID
- SELPET
- Acronym
- SELPET
- Status last verified
- Apr 2025
- First submitted
- 10 Jun 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Pathology Related to Slowly Expanding Lesions Using Advanced Imaging
- ClinicalTrials.gov ID
- NCT06460077
- Acronym / sponsor ID
- SELPET / SELPET
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Jun 2024 (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 is an open, follow-up study to compare the performance of three critical imaging methods to detect chronic active lesions in Multiple Sclerosis (MS) in vivo.
Detailed description
Smoldering inflammation is recognized as a critical contributor to MS progression-related central nervous system (CNS) damage. Activated microglia and macrophages particularly at chronic lesion edge are believed to promote lesion growth. Reversing their harmful activity may prove to be an efficient way to halt progression independent of relapses in MS.
These smoldering, or chronic active lesions can be detected in vivo using advanced imaging techniques. 1) Specific algorithms can be used to identify lesion growth, with a hypothesis that the slowly evolving lesions (SEL) are the ones harboring a rim of activated microglial cells, which contribute to damage in the surrounding tissue, and lesion growth. 2) Lesions partially or entirely surrounded by rims of increased tissue intensity on QSM-MRI (quantitative susceptibility mapping) sequences are considered as iron rim lesions, with iron-containing proinflammatory microglia/macrophages at the lesion edge. 3) In addition, 18 kDa translocator protein-positron emission tomography (TSPO-PET) imaging can be used to identify chronic active lesions based on TSPO-expression by activated innate immune cells, and their gathering at the edges of chronic active lesions. The TSPO-PET analysis of chronic active lesions can be semi-automated, and the specific radioligand binding at the chronic active lesion edge can be quantitated, which enhances the sensitivity of this method.
Despite existing preliminary data demonstrating increased QSM signal TSPO-positive lesions, it is yet to be demonstrated how these three imaging methods perform in identifying chronic active lesions when compared to each other at larger scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Multiple Sclerosis | – | –Patients who have previously participated in PET-imaging studies and from whom slowly expanding lesions as well as TSPO-rim-positive lesions and iron rims at the edge of lesions are found |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 52 MS patients with simultaneous QSM-MRI and TSPO-PET and with available longitudinal brain MRI images (minimum 1 year) have been identified. With an average detection frequency of >= 1 SEL in 70% of MS patients, there will be sufficient imaging material for successful conduct of the study.
Key inclusion criteria (5 listed)
- Signing the informed consent form
- MS diagnosis in accordance with McDonald 2017 criteria
- Available longitudinal brain MR images (minimum 1 year)
- Simultaneous QSM MRI sequence and TSPO-PET
- Lesions with iron rim/s
Key exclusion criteria (10 listed)
- Patients with other neurodegenerative disease than MS
- Patients with other autoimmune disease than MS
- Patients with other significant or malignant underlying disease of any other organ system
- Patients that are pregnant or breast-feeding
- Corticosteroid treatment within 4 weeks of imaging
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
Number of lesions
Time frame: 18 months, 36 months
The number of lesions identified using each respective method
Co-localization of lesions
Time frame: 18 months, 36 months
Potential co-localization of the RIM+ lesions identified using the various methods.
4 secondary outcomes
Correlation of PET imaging and clinical variables
Time frame: 18 months, 36 months
Correlation of magnetic resonance imaging and clinical variables
Time frame: 18 months, 36 months
Correlation of quality of life questionnaires and clinical variables
Time frame: 18 months, 36 months
Correlation of neuropsychological evaluation and clinical variables
Time frame: 18 months, 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
Related trials for Multiple Sclerosis
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
Active, not recruiting
MS-DETECT: Early Detection of Multiple Sclerosis Progression With MSCopilot® Detect
Multiple Sclerosis
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.
Laura Airas, MD,Professor principal investigator
Turku University Hospital, division of clinical neurosciences
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 Turku University Hospital at 1 site in Finland.
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 5 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 16 Apr 2025. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of lesions (time frame: 18 months, 36 months). 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 16 Apr 2025.