NCT07108712

Brief Summary

To assess the sensitivity and accuracy of diffusion magnetic resonance imaging (MRI), including diffusion-weighted imaging (DWI) metrics, in identifying early-stage changes in brain white matter related to various white matter diseases.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

July 31, 2025

Last Update Submit

July 31, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of diffusion magnetic resonance imaging

    Sensitivity of diffusion magnetic resonance imaging to predict the early evaluation of brain white matter diseases

    Immediately after diffusion magnetic resonance imaging (Up to 1 hour)

Study Arms (1)

Study group

Patients diagnosed with suspected early-stage white matter disease (e.g., multiple sclerosis, small vessel disease, Alzheimer's disease, frontotemporal dementia, leukoaraiosis) will be enrolled.

Other: Magnetic Resonance Imaging (MRI)

Interventions

Magnetic Resonance Imaging (MRI) Scanner: All imaging will be performed using a 1.5 tesla MRI scanner to ensure high resolution and signal-to-noise ratio.

Study group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will be a multicenter, cross-sectional study will be conducted on patients diagnosed with suspected early-stage white matter disease (e.g., multiple sclerosis, small vessel disease, Alzheimer's disease, frontotemporal dementia, leukoaraiosis) will be enrolled. Healthy age-matched controls will also be included for comparison.

You may qualify if:

  • Adults aged 18-80 years.
  • Clinical suspicion of early-stage white matter disease.
  • No prior diagnosis of significant neurological disorders (e.g., stroke, brain tumors).
  • Ability to provide informed consent.

You may not qualify if:

  • Pregnancy or breastfeeding.
  • Contraindications for magnetic resonance imaging (MRI) (e.g., metal implants, pacemakers).
  • Severe psychiatric or cognitive impairment that prevents participation.
  • Control Group: Healthy individuals without any clinical history of neurological diseases, matched by age and sex to the patient cohort.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Authority for Teaching Hospitals and Institutes

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Central Study Contacts

Hekmat S Baumey, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Diagnostic Radiology, Damnhour National Medical Institute

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 7, 2025

Study Start

May 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations