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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05391906
Other study ID # TiffanySo
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 30, 2023
Est. completion date December 30, 2026

Study information

Verified date February 2024
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Intravoxel incoherent motion (IVIM) is technique based on diffusion-weighted imaging (DWI). In this study, the investigators evaluate the use of IVIM in patients with Multiple Sclerosis.


Description:

Intravoxel incoherent motion (IVIM) is technique based on diffusion-weighted imaging (DWI), it is achieved through an MRI acquisition with multiple small b value to extract perfusion data. It has been shown to be a promising technique in evaluation of many brain conditions. This study seeks to assess intravoxel incoherent motion (IVIM) parameters in characterizing plaques and specific tissues in multiple sclerosis.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date December 30, 2026
Est. primary completion date December 20, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients who are 18 years or older. 2. Relapsing-remitting MS diagnosed as per Macdonald criteria Exclusion Criteria: 1. Contraindication to MRI. For example, metal implantation in the body, claustrophobia and pregnancy. 2. Patients who are unable to tolerate the scans without moving the head as a result of symptoms such as tremor, spasticity, involuntary movements and spasms, cognitive impairment, coughing, and shortness of breath.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Diffusion-weighted magnetic resonance imaging
Diffusion-weighted magnetic resonance imaging

Locations

Country Name City State
Hong Kong CUHK Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary IVIM parameters (including ADC,D,D*,f) in Multiple Sclerosis brain regions. Primary Outcome Measure:
1. IVIM parameters (including ADC,D,D*,f) in Multiple Sclerosis brain regions. The parameters are calculated based on a IVIM model bi-exponential model represented by: S(b)/S(0)=f ×exp(-bD*)+ (1-f)×exp(-bD), and the mono-exponential model for ADC calculation as represented by: S(b)/S(0)=exp(-bADC), where S(b) and S (0) are the MRI signal intensities at a given b value and b = 0, respectively.
ADC: apparent diffusion coefficient. ADC is expressed in units of mm2/s.
f: the perfusion or (micro) vascular volume fraction which depends on capillary geometry and blood velocity. f is expressed in units of mm2/s.
D*: pseudo diffusion coefficient that resembles the perfusion related incoherent microcirculation. D* is expressed in units of mm2/s.
D: pure diffusion coefficient which is related to pure molecular diffusion. D is expressed in units of mm2/s.
Up to 2 months
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