Anatomical Variants of Dural Sinuses by Magnetic Resonance VenographyNCT06253936
Prevalence of Anatomical Variants of Dural Sinuses by Magnetic Resonance Venography Evaluation in Sohag
An observational study of Anatomical Variants of Dural Sinuses by Magnetic Resonance Venography, run by Sohag University at 1 site in Egypt.
Trial summary
MR cerebral venography (MRV) is an MRI examination of the head with either contrast-enhanced or non-contrast sequences to assess patency of the dural venous sinuses and cerebral veins. Read more about this study
- Who is it for?
- Ages 7 days to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Anatomical Variants of Dural Sinuses by Magnetic Resonance Venography
- What is being tested?
- Magnetic Resonance Venography
- How many people
- 169 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2024to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 days to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Sohag by nationality and residence, male or female by sex, having normal cerebral MRV reported and consented to participate in the research work will be included in this research.
Who may be able to join
- Sohag by nationality and residence, male or female by sex, having normal cerebral MRV reported and consented to participate in the research work will be included in this research.
Who cannot join
- Having the diagnosis of cerebral venous sinus thrombosis, and previous head injury are the exclusion criteria of this research, also patients with absolute or relative contraindications for imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.
Trial locations and contacts
1 site in 1 country.
Mohamed Tharwat Mahmoud Solyman, Professor doctor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Magdy M Amin, Professor
About this study
MR cerebral venography (MRV) is an MRI examination of the head with either contrast-enhanced or non-contrast sequences to assess patency of the dural venous sinuses and cerebral veins.
- Being tested
- Magnetic Resonance Venography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance VenographyOther
Detect the anatomical variants of dural sinuses by Magnetic Resonance Venography
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of anatomical variants of dural sinuses by Magnetic Resonance Venography evaluation in Sohag
The primary outcome for the study is to assess the number of anatomical variants of dural sinuses by MRV evaluation among patients attended to Sohag University Hospitals. Standard head coils with small field of view and thin sections will be used for the examination. Routine MRI brain including Axial T1WI, T2WI, FLAIR, Coronal T2WI, and Sagittal T1 WI will be done with complementary Maximum intensity projection (MIP) 3D MR venography. Imaging findings of the veins and sinuses will be recorded using Philips Achieva1.5T MRI device (Philips Achieva, Netherlands) or Siemens Magnetom Altea1.5T MRI device (Siemens Healthineers, Germany). Any anatomic variants in these sinuses or their drainage, if any, will be recorded.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start2 Feb 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomical Variants of Dural Sinuses by Magnetic Resonance VenographyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 169 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Makram Sabah, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253936
- Sponsor's protocol ID
- Soh-Med-24-01-01MS
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Anatomical Variants of Dural Sinuses by Magnetic Resonance Venography Evaluation in Sohag
- ClinicalTrials.gov ID
- NCT06253936
- Acronym / sponsor ID
- Soh-Med-24-01-01MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 169 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 12 Feb 2024 (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.
MR cerebral venography (MRV) is an MRI examination of the head with either contrast-enhanced or non-contrast sequences to assess patency of the dural venous sinuses and cerebral veins.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 days to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sohag by nationality and residence, male or female by sex, having normal cerebral MRV reported and consented to participate in the research work will be included in this research.
Key inclusion criteria (1 listed)
- Sohag by nationality and residence, male or female by sex, having normal cerebral MRV reported and consented to participate in the research work will be included in this research.
Key exclusion criteria (1 listed)
- Having the diagnosis of cerebral venous sinus thrombosis, and previous head injury are the exclusion criteria of this research, also patients with absolute or relative contraindications for imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.
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 VenographyDetect the anatomical variants of dural sinuses by Magnetic Resonance Venography | Other | – |
Primary outcome
Number of anatomical variants of dural sinuses by Magnetic Resonance Venography evaluation in Sohag
Time frame: 1 year
The primary outcome for the study is to assess the number of anatomical variants of dural sinuses by MRV evaluation among patients attended to Sohag University Hospitals. Standard head coils with small field of view and thin sections will be used for the examination. Routine MRI brain including Axial T1WI, T2WI, FLAIR, Coronal T2WI, and Sagittal T1 WI will be done with complementary Maximum intensity projection (MIP) 3D MR venography. Imaging findings of the veins and sinuses will be recorded using Philips Achieva1.5T MRI device (Philips Achieva, Netherlands) or Siemens Magnetom Altea1.5T MRI device (Siemens Healthineers, Germany). Any anatomic variants in these sinuses or their drainage, if any, will be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: Yes
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. This study is not recruiting at the moment.
Mohamed Tharwat Mahmoud Solyman, Professor doctor contact
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 Anatomical Variants of Dural Sinuses by Magnetic Resonance Venography, run by Sohag University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Makram Sabah, Resident (01002701905, nanamakram20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of anatomical variants of dural sinuses by Magnetic Resonance Venography evaluation in Sohag (time frame: 1 year). 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 12 Feb 2024.