Diffusion Magnetic Resonance ImagingNCT07108712
Diffusion Magnetic Resonance Imaging (dMRI) in the Early Evaluation of Brain White Matter Diseases
An observational study of Diffusion Magnetic Resonance Imaging and Brain White Matter Diseases, run by The General Authority for Teaching Hospitals and Institutes at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffusion Magnetic Resonance Imaging, Brain White Matter Diseases
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
General Authority for Teaching Hospitals and Institutes
Cairo
Hekmat S Baumey, MD, 00201555433546, hekmattsamir@gmail.com
About this study
Official title: The Role of Diffusion Magnetic Resonance Imaging (dMRI) in the Early Evaluation of Brain White Matter Diseases
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.
Read the detailed description
Brain white matter diseases (WMDs) are a group of neurological conditions that involve changes to the brain's white matter, often leading to cognitive, motor, and sensory impairments.
Diffusion Magnetic Resonance Imaging (dMRI), has emerged as a powerful non-invasive imaging tool for evaluating microstructural changes in brain white matter. This protocol aims to investigate the role of dMRI in the early identification and characterization of brain white matter diseases, focusing on its potential for detecting abnormalities before the onset of overt clinical symptoms.
Diffusion-weighted imaging (DWI), one of the first advanced magnetic resonance imaging (MRI) techniques, has rapidly ascended on the basis of its applicability in strokes and some infectious diseases. Restricted diffusion is significant information in the context of vascular ischemia, helping to delimit the brain-damaged area
- Being tested
- Magnetic Resonance Imaging (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Other
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of diffusion magnetic resonance imaging
Sensitivity of diffusion magnetic resonance imaging to predict the early evaluation of brain white matter diseases
Measured: Immediately after diffusion magnetic resonance imaging (Up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 May 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffusion Magnetic Resonance ImagingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The General Authority for Teaching Hospitals and Institutes
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Hekmat Samir Baumey, The General Authority for Teaching Hospitals and Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108712
- Sponsor's protocol ID
- HD000235
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Diffusion Magnetic Resonance Imaging (dMRI) in the Early Evaluation of Brain White Matter Diseases
- ClinicalTrials.gov ID
- NCT07108712
- Acronym / sponsor ID
- HD000235
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The General Authority for Teaching Hospitals and InstitutesResearch network
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Brain white matter diseases (WMDs) are a group of neurological conditions that involve changes to the brain's white matter, often leading to cognitive, motor, and sensory impairments.
Diffusion Magnetic Resonance Imaging (dMRI), has emerged as a powerful non-invasive imaging tool for evaluating microstructural changes in brain white matter. This protocol aims to investigate the role of dMRI in the early identification and characterization of brain white matter diseases, focusing on its potential for detecting abnormalities before the onset of overt clinical symptoms.
Diffusion-weighted imaging (DWI), one of the first advanced magnetic resonance imaging (MRI) techniques, has rapidly ascended on the basis of its applicability in strokes and some infectious diseases. Restricted diffusion is significant information in the context of vascular ischemia, helping to delimit the brain-damaged area
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Magnetic Resonance Imaging (MRI)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)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. | Other | Study group |
Primary outcome
Sensitivity of diffusion magnetic resonance imaging
Time frame: Immediately after diffusion magnetic resonance imaging (Up to 1 hour)
Sensitivity of diffusion magnetic resonance imaging to predict the early evaluation of brain white matter diseases
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffusion Magnetic Resonance Imaging and Brain White Matter Diseases, run by The General Authority for Teaching Hospitals and Institutes at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hekmat S Baumey, MD (00201555433546, hekmattsamir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of diffusion magnetic resonance imaging (time frame: Immediately after diffusion magnetic resonance imaging (Up to 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.