Intravoxel Incoherent Motion (IVIM) Magnetic Resonance Imaging in Multiple Sclerosis

March 9, 2025 updated by: Professor Tiffany So, Chinese University of Hong Kong
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravoxel Incoherent Motion(IVIM) MRI
Intravoxel incoherent motion (IVIM) is based on diffusion-weighted imaging (DWI)
Other: Diffusion-weighted magnetic resonance imaging
Diffusion-weighted magnetic resonance imaging
Other Names:
  • Diffusion-weighted magnetic resonance imaging uses the diffusion of water molecules to generate contrast in MR images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IVIM parameters (including ADC,D,D*,f) in Multiple Sclerosis brain regions.
Time Frame: Up to 2 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

May 22, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 9, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TiffanySo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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