Multiple SclerosisNCT04521439
Accurate Diagnosis of Multiple Sclerosis Using PET/MR
A study testing 18F-florbetapir PET+MRSI in people with Multiple Sclerosis, run by Ruijin Hospital at 1 site in China.
Trial summary
Multiple sclerosis (MS) is an immune-mediated chronic inflammatory demyelinating disease of the central nervous system. Its main feature is progressive demyelination, which ultimately leads to axon damage and neuron loss. MR is the main imaging technique in the current diagnostic criteria of MS. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- 18F-florbetapir PET+MRSI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 30 Jul 2022
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 18-65 years old;
- diagnosed with mild or moderate disease (EDSS score ≤ 5 points); it meets the 2017 new version of McDonald diagnostic criteria for multiple sclerosis.
- meet the diagnostic criteria of clinically isolated syndromes (CIS)
- between 18-65 years old;
- able to understand the purpose of clinical research and test plan;
- In the brain MR assessment, it is judged as "normal (corresponding to age)"
Who cannot join
- No brain surgery/no brain trauma/no history of brain disease (stroke), no other independent neurological or psychiatric history;
- No severe depression symptoms;
- No alcoholism or drug dependence (addiction);
- No other conditions that affect the smooth progress of the inspection: such as hearing impairment, comprehension impairment, poor compliance, etc.;
- No rheumatic diseases and other acute or chronic inflammations (required for hematological markers).
- No MR contrast agent allergy
Show all 15Show fewer
- Healthy Volunteers Group:
- Any major mental illness; history of schizophrenia or schizoaffective disorder
- Any important neurological disease, such as cerebrovascular disease, inflammation or infectious disease, demyelinating disease, neurodegenerative disease, history of epilepsy or history of physical or craniocerebral trauma or brain surgery or intracranial hematoma with permanent brain history of injury;
- Brain MR has pathological manifestations;
- Any major diseases or unstable conditions (such as unstable angina, myocardial infarction or coronary revascularization within 12 months before enrollment, heart failure, chronic renal failure, chronic liver disease, severe lung disease, blood disease, poorly controlled diabetes, chronic infections);
- Medical history of tumors (except skin or prostate cancer in situ) within 5 years before screening;
- High risk of drug allergy (such as patients with allergic asthma) or history of severe allergic reactions to allergens;
- History of alcohol or drug abuse/dependence;
- MR contraindications (such as pacemaker or nerve stimulator or metal foreign body, high fever, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hybrid PET/MR Imaging to Assess Demyelination and Axonal Injury in Multiple Sclerosis
Multiple sclerosis (MS) is an immune-mediated chronic inflammatory demyelinating disease of the central nervous system. Its main feature is progressive demyelination, which ultimately leads to axon damage and neuron loss. MR is the main imaging technique in the current diagnostic criteria of MS. The conventional MR sequence recommended in this diagnostic criteria has high sensitivity for detecting demyelination and axon damage, but has poor specificity, which makes disease modification therapy (DMT) blind, and it is also difficult to accurately determine the long-term prognosis.
PET is a non-invasive molecular imaging technology that can quantitatively monitor physiological or pathological processes in vivo. 18F-labeled thioflavin derivative probe (18F-florbetapir) can bind to myelin basic protein in the white matter, providing quantitative assessment of myelin content. Our preliminary studies have confirmed that the uptake of 18F-florbetapir in MS lesions is significantly related to the myelin content measured by histological staining. Therefore, 18F-florbetapir PET may be a very effective myelin imaging technology.
Read more
Advanced MR sequence such as magnetic resonance spectroscopy (MRS) can evaluate axonal damage by analyzing neuronal activity marker N-acetyl aspartate (NAA). The new whole-brain fast 3D MRS sequence breaks through the bottleneck of low signal-to-noise ratio and spatial resolution of the current MRS sequence, and provides a reliable method for obtaining neuronal activity markers in the three-dimensional space of MS sporadic lesions in the whole brain.
Integrated PET/MR makes PET detector implant in the MR magnet, which realizes the simultaneous acquisition of PET and MR in one scan, ensuring the high consistency of the two modes. This makes it possible to simultaneously analyze PET and MRS quantitative parameters in multiple and different sizes of MS lesions, that is, to obtain two different pathological features of demyelination and neuronal damage. Separating these two pathological changes will help to more accurately and quantitatively evaluate the efficacy of DMT, program selection and prognostic judgment.
This project intends to recruit 30 MS patients between 18-65 years old, and 30 healthy volunteers with matched age and sex as normal controls. PET/MR imaging, serological examination and cerebrospinal fluid testing and scale evaluation will be performed. The aim of this project is to planned to establish a new imaging evaluation technology for accurate diagnosis and prognosis evaluation of MS.
- Conditions
- Multiple Sclerosis
- Being tested
- 18F-florbetapir PET+MRSI
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-florbetapir PET+MRSIDiagnostic test
PET and MRS quantitative parameters in MS lesions are simultaneously analyzed using hybrid PET/MR for obtaining demyelination and neuronal damage information.
| Study group | Role | What they receive |
|---|---|---|
| MS Patients Group | Experimental | Not described Receives: Diagnostic Test: 18F-florbetapir PET+MRSI |
| Healthy Volunteers Group | Sham comparator | Not described Receives: Diagnostic Test: 18F-florbetapir PET+MRSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution Volume Ratio (DVR)
Dynamic parameter of 18F-florbetapir distribution for quantitatively assessing the demyelination
Measured: Baseline
Change from Baseline DVR at 6 months
Change of 18F-florbetapir distribution in the demyelinated lesions after 6 months
Measured: 6 months after baseline
Change from Baseline DVR at 1 year
Change of 18F-florbetapir distribution in the demyelinated lesions after 1 year
Measured: 1 year after baseline
Standardized Uptake Value Ratio (SUVR)
Static parameter of 18F-florbetapir uptake for quantitatively assessing the demyelination
Measured: Baseline
Change from Baseline SUVR at 6 months
Change of 18F-florbetapir uptake in the demyelinated lesions after 6 months
Measured: 6 months after baseline
Change from Baseline SUVR at 1 year
Change of 18F-florbetapir uptake in the demyelinated lesions after 1 year
Measured: 1 year after baseline
N-acetyl aspartate (NAA) quantification
Neuronal activity marker based on magnetic resonance spectroscopy imaging (MRSI)
Measured: Baseline
Change from Baseline NAA at 6 months
Change of neuronal activity marker in the demyelinated lesions after 6 months
Measured: 6 months after baseline
Change from Baseline NAA at 1 year
Change of neuronal activity marker in the demyelinated lesions after 1 year
Measured: 1 year after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start1 Feb 2020
- Primary completion30 Mar 2022
- Study completion30 Jul 2022
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 Ruijin 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521439
- Sponsor's protocol ID
- (2020)CER(126)
- Status last verified
- Mar 2022
- First submitted
- 14 Aug 2020
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid PET/MR Imaging to Assess Demyelination and Axonal Injury in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04521439
- Acronym / sponsor ID
- (2020)CER(126)
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 20 Aug 2020 (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.
Multiple sclerosis (MS) is an immune-mediated chronic inflammatory demyelinating disease of the central nervous system. Its main feature is progressive demyelination, which ultimately leads to axon damage and neuron loss. MR is the main imaging technique in the current diagnostic criteria of MS. The conventional MR sequence recommended in this diagnostic criteria has high sensitivity for detecting demyelination and axon damage, but has poor specificity, which makes disease modification therapy (DMT) blind, and it is also difficult to accurately determine the long-term prognosis.
PET is a non-invasive molecular imaging technology that can quantitatively monitor physiological or pathological processes in vivo. 18F-labeled thioflavin derivative probe (18F-florbetapir) can bind to myelin basic protein in the white matter, providing quantitative assessment of myelin content. Our preliminary studies have confirmed that the uptake of 18F-florbetapir in MS lesions is significantly related to the myelin content measured by histological staining. Therefore, 18F-florbetapir PET may be a very effective myelin imaging technology.
Advanced MR sequence such as magnetic resonance spectroscopy (MRS) can evaluate axonal damage by analyzing neuronal activity marker N-acetyl aspartate (NAA). The new whole-brain fast 3D MRS sequence breaks through the bottleneck of low signal-to-noise ratio and spatial resolution of the current MRS sequence, and provides a reliable method for obtaining neuronal activity markers in the three-dimensional space of MS sporadic lesions in the whole brain.
Integrated PET/MR makes PET detector implant in the MR magnet, which realizes the simultaneous acquisition of PET and MR in one scan, ensuring the high consistency of the two modes. This makes it possible to simultaneously analyze PET and MRS quantitative parameters in multiple and different sizes of MS lesions, that is, to obtain two different pathological features of demyelination and neuronal damage. Separating these two pathological changes will help to more accurately and quantitatively evaluate the efficacy of DMT, program selection and prognostic judgment.
This project intends to recruit 30 MS patients between 18-65 years old, and 30 healthy volunteers with matched age and sex as normal controls. PET/MR imaging, serological examination and cerebrospinal fluid testing and scale evaluation will be performed. The aim of this project is to planned to establish a new imaging evaluation technology for accurate diagnosis and prognosis evaluation of MS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS Patients Group | Experimental | Diagnostic Test: 18F-florbetapir PET+MRSI |
| Healthy Volunteers Group | Sham comparator | Diagnostic Test: 18F-florbetapir PET+MRSI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- between 18-65 years old;
- diagnosed with mild or moderate disease (EDSS score ≤ 5 points); it meets the 2017 new version of McDonald diagnostic criteria for multiple sclerosis.
- meet the diagnostic criteria of clinically isolated syndromes (CIS)
- between 18-65 years old;
- able to understand the purpose of clinical research and test plan;
Key exclusion criteria (15 listed)
- No brain surgery/no brain trauma/no history of brain disease (stroke), no other independent neurological or psychiatric history;
- No severe depression symptoms;
- No alcoholism or drug dependence (addiction);
- No other conditions that affect the smooth progress of the inspection: such as hearing impairment, comprehension impairment, poor compliance, etc.;
- No rheumatic diseases and other acute or chronic inflammations (required for hematological markers).
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 |
|---|---|---|
| 18F-florbetapir PET+MRSIPET and MRS quantitative parameters in MS lesions are simultaneously analyzed using hybrid PET/MR for obtaining demyelination and neuronal damage information. | Diagnostic test | Healthy Volunteers Group, MS Patients Group |
Primary outcome
Distribution Volume Ratio (DVR)
Time frame: Baseline
Dynamic parameter of 18F-florbetapir distribution for quantitatively assessing the demyelination
Change from Baseline DVR at 6 months
Time frame: 6 months after baseline
Change of 18F-florbetapir distribution in the demyelinated lesions after 6 months
Change from Baseline DVR at 1 year
Time frame: 1 year after baseline
Change of 18F-florbetapir distribution in the demyelinated lesions after 1 year
Standardized Uptake Value Ratio (SUVR)
Time frame: Baseline
Static parameter of 18F-florbetapir uptake for quantitatively assessing the demyelination
Change from Baseline SUVR at 6 months
Time frame: 6 months after baseline
Change of 18F-florbetapir uptake in the demyelinated lesions after 6 months
Change from Baseline SUVR at 1 year
Time frame: 1 year after baseline
Change of 18F-florbetapir uptake in the demyelinated lesions after 1 year
N-acetyl aspartate (NAA) quantification
Time frame: Baseline
Neuronal activity marker based on magnetic resonance spectroscopy imaging (MRSI)
Change from Baseline NAA at 6 months
Time frame: 6 months after baseline
Change of neuronal activity marker in the demyelinated lesions after 6 months
Change from Baseline NAA at 1 year
Time frame: 1 year after baseline
Change of neuronal activity marker in the demyelinated lesions after 1 year
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 25 Oct 2022.
Related trials for Multiple Sclerosis
Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Not yet recruitingObservational study
The Role of the FCRL5 Protein in the Pathophysiology of Multiple Sclerosis and Response to Treatment
Multiple Sclerosis
RecruitingObservational study
Development of a Novel Functional Eye-Tracking Software Application for Multiple Sclerosis
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
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?
A study testing 18F-florbetapir PET+MRSI in people with Multiple Sclerosis, run by Ruijin Hospital at 1 site in China.
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 6 inclusion and 15 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 25 Oct 2022. 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 China. 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. Some participants in this study may receive a placebo. 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?
Distribution Volume Ratio (DVR) (time frame: Baseline). The study lists 9 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 25 Oct 2022.