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Accurate Diagnosis of Multiple Sclerosis Using PET/MR

Hybrid PET/MR Imaging to Assess Demyelination and Axonal Injury in Multiple Sclerosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04521439
Enrollment
49
Registered
2020-08-20
Start date
2020-02-01
Completion date
2022-07-30
Last updated
2022-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief 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. 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.

Interventions

DIAGNOSTIC_TEST18F-florbetapir PET+MRSI

PET and MRS quantitative parameters in MS lesions are simultaneously analyzed using hybrid PET/MR for obtaining demyelination and neuronal damage information.

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

MS Patients Group: Inclusion Criteria: * 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)

Exclusion criteria

* 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 Healthy Volunteers Group: Inclusion Criteria: * 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)

Design outcomes

Primary

MeasureTime frameDescription
Distribution Volume Ratio (DVR)BaselineDynamic parameter of 18F-florbetapir distribution for quantitatively assessing the demyelination
Change from Baseline DVR at 6 months6 months after baselineChange of 18F-florbetapir distribution in the demyelinated lesions after 6 months
Change from Baseline DVR at 1 year1 year after baselineChange of 18F-florbetapir distribution in the demyelinated lesions after 1 year
Standardized Uptake Value Ratio (SUVR)BaselineStatic parameter of 18F-florbetapir uptake for quantitatively assessing the demyelination
Change from Baseline SUVR at 6 months6 months after baselineChange of 18F-florbetapir uptake in the demyelinated lesions after 6 months
Change from Baseline SUVR at 1 year1 year after baselineChange of 18F-florbetapir uptake in the demyelinated lesions after 1 year
N-acetyl aspartate (NAA) quantificationBaselineNeuronal activity marker based on magnetic resonance spectroscopy imaging (MRSI)
Change from Baseline NAA at 6 months6 months after baselineChange of neuronal activity marker in the demyelinated lesions after 6 months
Change from Baseline NAA at 1 year1 year after baselineChange of neuronal activity marker in the demyelinated lesions after 1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026