Multiple SclerosisNCT05391906
Intravoxel Incoherent Motion (IVIM) Magnetic Resonance Imaging in Multiple Sclerosis
A study testing Diffusion-weighted magnetic resonance imaging in people with Multiple Sclerosis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Diffusion-weighted magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Jan 2023to 30 Dec 2026
- Phase
- Interventional
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are 18 years or older.
- Relapsing-remitting MS diagnosed as per Macdonald criteria
Who cannot join
- Contraindication to MRI. For example, metal implantation in the body, claustrophobia and pregnancy.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Diffusion-weighted magnetic resonance imaging
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion-weighted magnetic resonance imagingOther
Also called Diffusion-weighted magnetic resonance imaging uses the diffusion of water molecules to generate contrast in MR images.
Diffusion-weighted magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| Intravoxel Incoherent Motion(IVIM) MRI | Experimental | Intravoxel incoherent motion (IVIM) is based on diffusion-weighted imaging (DWI) Receives: Other: Diffusion-weighted magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
IVIM parameters (including ADC,D,D*,f) in Multiple Sclerosis brain regions.
Primary Outcome Measure:
- 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.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start30 Jan 2023
- Primary completion20 Dec 2026 (estimated)
- Study completion30 Dec 2026 (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 Chinese University of Hong KongThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Tiffany So, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391906
- Sponsor's protocol ID
- TiffanySo
- Status last verified
- Mar 2026
- First submitted
- 3 May 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No