NCT05391906

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
8mo left

Started Jan 2023

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Jan 2023Dec 2026

First Submitted

Initial submission to the registry

May 3, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

3.9 years

First QC Date

May 3, 2022

Last Update Submit

March 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Intravoxel Incoherent Motion(IVIM) MRI

EXPERIMENTAL

Intravoxel incoherent motion (IVIM) is based on diffusion-weighted imaging (DWI)

Other: Diffusion-weighted magnetic resonance imaging

Interventions

Diffusion-weighted magnetic resonance imaging

Also known as: Diffusion-weighted magnetic resonance imaging uses the diffusion of water molecules to generate contrast in MR images.
Intravoxel Incoherent Motion(IVIM) MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are 18 years or older.
  • Relapsing-remitting MS diagnosed as per Macdonald criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CUHK

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

May 3, 2022

First Posted

May 26, 2022

Study Start

January 30, 2023

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations