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

Primary Purpose

Multiple Sclerosis

Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Diffusion-weighted magnetic resonance imaging
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CUHK

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravoxel Incoherent Motion(IVIM) MRI

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2022
Last Updated
February 10, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05391906
Brief Title
Intravoxel Incoherent Motion (IVIM) Magnetic Resonance Imaging in Multiple Sclerosis
Official Title
Intravoxel Incoherent Motion (IVIM) Magnetic Resonance Imaging in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravoxel Incoherent Motion(IVIM) MRI
Arm Type
Experimental
Arm Description
Intravoxel incoherent motion (IVIM) is based on diffusion-weighted imaging (DWI)
Intervention Type
Other
Intervention Name(s)
Diffusion-weighted magnetic resonance imaging
Other Intervention Name(s)
Diffusion-weighted magnetic resonance imaging uses the diffusion of water molecules to generate contrast in MR images.
Intervention Description
Diffusion-weighted magnetic resonance imaging
Primary Outcome Measure Information:
Title
IVIM parameters (including ADC,D,D*,f) in Multiple Sclerosis brain regions.
Description
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.
Time Frame
Up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who are 18 years or older. Relapsing-remitting MS diagnosed as per Macdonald criteria Exclusion Criteria: 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.
Facility Information:
Facility Name
CUHK
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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