Multiple SclerosisFINGOPETNCT02139696
Sphingosine-1 Phosphate -Receptor Targeting and Microglial Activation
An observational study of Multiple Sclerosis, run by Turku University Hospital at 1 site in Finland.
Trial summary
To evaluate the usability of positron emission tomography imaging as a novel outcome measure in multiple sclerosis studies Read more about this study
- Who is it for?
- Ages 18 to 58 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- PET and MRI
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2013to Oct 2016
- 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 58 years
- All sexes
- No healthy volunteers
- Adult
Study population: 10 patients with multiple sclerosis who will be initiated on fingolimod in the neurology outpatient clinic of the Turku University hospital in Turku, Finland.
Who may be able to join
- Having signed the informed consent of the investigator-initiated PET study
- Age 18 - 58 years at the time of informed consent.
- MS according to Poser or McDonald criteria
- EDSS score from 0.0 to 6.5.
- Moderate to heavy lesion load ( >9 T2 lesions) in MRI
Who cannot join
- - Patients with other neurodegenerative disease than MS
- Disease modifying therapy (DMT) within 4 weeks of imaging
- Corticosteroid treatment within 4 weeks of imaging
- Patients with significant abnormal findings other than MS in the screening MRI.
- 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.
About this study
Official title: Does Targeting of Sphingosine-1 Phosphate Receptors Reduce Microglial Activation in Multiple Sclerosis? A [11C]PK11195 Brain PET Study
To evaluate the usability of positron emission tomography imaging as a novel outcome measure in multiple sclerosis studies
Read the detailed description
Background and Rationale
In multiple sclerosis (MS), significant pathology correlating to disease progression, to expanded disability status scale (EDSS) and to cognitive decline, takes place outside the plaque areas, i.e. in areas of normal appearing white matter and gray matter. Neuropathological studies suggest that mechanisms involved in this widespread pathology include activation of microglial cells, oxidative stress and deficiency in mitochondrial functions. Activated microglia can be detected in vivo with a translocator protein (TSPO), expressed in activated, but not resting microglia) binding radioligands and positron emission tomography (PET). 11Carbon-PK11195 radioligand is one such radioligand. Importantly, the possible effect of MS therapies on microglial activity can be evaluated in patients in vivo with PET-imaging performed before and after the treatment.
- Conditions
- Multiple Sclerosis
- Being tested
- PET and MRI
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET and MRIRadiation
Patients will be imaged using PET and MRI at baseline, and twice during treatment
| Study group | Role | What they receive |
|---|---|---|
| MS patients initiating fingolimod | Patients will be imaged using PET and MRI at baseline, and twice during treatment. Receives: Radiation: PET and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 11C-PK11195-radioligand binding using PET
Patients will be switched to fingolimod from first-line therapies as per indication and as part of their normal treatment regimen, and those who will consent to participate in this investigator-initiated PET study, will be imaged at baseline (pre-treatment phase) and after 6-8 weeks and 24 weeks of treatment. Purpose is to compare the binding of the radioligand between these three time points.
Measured: 0 to 24 weeks
Secondary outcomes (1)
MRI metrics
To evaluate the total lesion load of the white matter MS plaques with MRI; baseline vs. 6-8 weeks vs. 24 weeks of Gilenya treatment
Measured: 0, 6-8 wk, 24 wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startSep 2013
- Primary completionJan 2015
- Study completionOct 2016
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 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Laura Airas, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139696
- Sponsor's protocol ID
- FINGOPET
- Acronym
- FINGOPET
- Status last verified
- May 2018
- First submitted
- 8 May 2014
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Rissanen E, Tuisku J, Rokka J, Paavilainen T, Parkkola R, Rinne JO, Airas L. In Vivo Detection of Diffuse Inflammation in Secondary Progressive Multiple Sclerosis Using PET Imaging and the Radioligand (1)(1)C-PK11195. J Nucl Med. 2014 Jun;55(6):939-44. doi: 10.2967/jnumed.113.131698. Epub 2014 Apr 7.
PubMed 24711650
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Targeting of Sphingosine-1 Phosphate Receptors Reduce Microglial Activation in Multiple Sclerosis? A [11C]PK11195 Brain PET Study
- ClinicalTrials.gov ID
- NCT02139696
- Acronym / sponsor ID
- FINGOPET / FINGOPET
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 15 May 2014 (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.
To evaluate the usability of positron emission tomography imaging as a novel outcome measure in multiple sclerosis studies
Detailed description
Background and Rationale
In multiple sclerosis (MS), significant pathology correlating to disease progression, to expanded disability status scale (EDSS) and to cognitive decline, takes place outside the plaque areas, i.e. in areas of normal appearing white matter and gray matter. Neuropathological studies suggest that mechanisms involved in this widespread pathology include activation of microglial cells, oxidative stress and deficiency in mitochondrial functions. Activated microglia can be detected in vivo with a translocator protein (TSPO), expressed in activated, but not resting microglia) binding radioligands and positron emission tomography (PET). 11Carbon-PK11195 radioligand is one such radioligand. Importantly, the possible effect of MS therapies on microglial activity can be evaluated in patients in vivo with PET-imaging performed before and after the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS patients initiating fingolimod | – | Radiation: PET and MRIPatients will be imaged using PET and MRI at baseline, and twice during treatment. |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 10 patients with multiple sclerosis who will be initiated on fingolimod in the neurology outpatient clinic of the Turku University hospital in Turku, Finland.
Key inclusion criteria (5 listed)
- Having signed the informed consent of the investigator-initiated PET study
- Age 18 - 58 years at the time of informed consent.
- MS according to Poser or McDonald criteria
- EDSS score from 0.0 to 6.5.
- Moderate to heavy lesion load ( >9 T2 lesions) in MRI
Key exclusion criteria (8 listed)
- - Patients with other neurodegenerative disease than MS
- Disease modifying therapy (DMT) within 4 weeks of imaging
- Corticosteroid treatment within 4 weeks of imaging
- Patients with significant abnormal findings other than MS in the screening MRI.
- 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)
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 |
|---|---|---|
| PET and MRIPatients will be imaged using PET and MRI at baseline, and twice during treatment | Radiation | MS patients initiating fingolimod |
Primary outcome
Change of 11C-PK11195-radioligand binding using PET
Time frame: 0 to 24 weeks
Patients will be switched to fingolimod from first-line therapies as per indication and as part of their normal treatment regimen, and those who will consent to participate in this investigator-initiated PET study, will be imaged at baseline (pre-treatment phase) and after 6-8 weeks and 24 weeks of treatment. Purpose is to compare the binding of the radioligand between these three time points.
1 secondary outcome
MRI metrics
Time frame: 0, 6-8 wk, 24 wk
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 11 May 2018.
- Background: PubMed 24711650Rissanen E, Tuisku J, Rokka J, Paavilainen T, Parkkola R, Rinne JO, Airas L. In Vivo Detection of Diffuse Inflammation in Secondary Progressive Multiple Sclerosis Using PET Imaging and the Radioligand (1)(1)C-PK11195. J Nucl Med. 2014 Jun;55(6):939-44. doi: 10.2967/jnumed.113.131698. Epub 2014 Apr 7.
- Individual participant dataSharing planned: Undecided
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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.
Laura Airas, MD, PhD principal investigator
Turku University Hospital
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 8 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 11 May 2018. 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?
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?
Change of 11C-PK11195-radioligand binding using PET (time frame: 0 to 24 weeks). 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 NCT02139696, 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 11 May 2018.