Cerebrospinal FluidNCT03656016
Assessment of Cerebrospinal Fluid Flow Related Disorders Using a Phase-contrast Magnetic Resonance Imaging Technique.
An observational study of Cerebrospinal Fluid, run by Assiut University at 1 site in Egypt.
Trial summary
Cerebrospinal fluid is a clear, colorless fluid that circulates in the cranial and spinal subarachnoid spaces, located between the pia and arachnoid matters. It is mainly produced by the choroid plexus, while lesser amount produced by the ependymal cells lining the ventricles. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cerebrospinal Fluid
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Medical device
- How many people
- 87 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2019to Jul 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with different age groups and both sex with clinical and routine conventional magnetic resonance imaging findings suggestive of cerebrospinal fluid flow disorders
Who may be able to join
- Patients with different age groups and both sex with clinical and routine conventional magnetic resonance imaging findings suggestive of cerebrospinal fluid flow disorders.
Who cannot join
- Patients with contraindications for MRI, e.g. an implanted magnetic device, pacemakers or claustrophobia.
- Patients with VP shunts
- Patients with ventriculomegally due to brain SOLs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine
Asyut, 71111
Mostafa Thabet, MD, 01122999878, thabet.mostafa@yahoo.com
Marwa Ahmed, MD, 01006541595, drmarwa201198@ymail.com
About this study
Cerebrospinal fluid is a clear, colorless fluid that circulates in the cranial and spinal subarachnoid spaces, located between the pia and arachnoid matters. It is mainly produced by the choroid plexus, while lesser amount produced by the ependymal cells lining the ventricles. Its function includes cushioning and lubrication of the central nervous system, circulation of nutrients and waste collection providing basic mechanical and immunological protection to the brain.
Read the detailed description
There are several disorders such as communicating and non- communicating hydrocephalus, normal pressure hydrocephalus, cystic cerebrospinal fluid collections, Chiari malformation, syringomyelic cyst and arachnoid cyst that can change the cerebrospinal fluid dynamics.
Rapid advances in imaging techniques have remarkably improved the diagnosis and treatment of these disorders.
Phase contrast magnetic resonance imaging is a rapid, simple and non-invasive technique which is sensitive to even small cerebrospinal fluid flows, and can be used to evaluate cerebrospinal fluid flow both qualitatively and quantitatively. Cine phase contrast magnetic resonance images show cerebrospinal fluid flow in a dynamic, more easily appreciable, and in a more pleasing manner, allowing the delineation of obstruction, if present, along the portions of cerebrospinal fluid pathway where obstruction is common.
Phase contrast magnetic resonance imaging can be used to discriminate between communicating hydrocephalus and non-communicating hydrocephalus, to localize the level of obstruction in obstructive hydrocephalus, to determine whether arachnoid cysts communicate with the subarachnoid space, to differentiate between arachnoid cysts and subarachnoid space, to discriminate between syringomyelia and cystic myelomalacia, and to evaluate flow patterns of posterior fossa cystic malformations.
This imaging method can also provide significant information in pre-operative evaluation of Chiari 1 malformation and post-operative follow-up of patients with neuroendoscopic third ventriculostomy and ventriculoperitoneal shunt.
The application of cine phase contrast magnetic resonance imaging technique in patients with normal pressure hydrocephalus holds great promise for improvement of the diagnosis, especially in those cases where the differentiation from atrophy on clinical and conventional radiological basis is difficult.
- Conditions
- Cerebrospinal Fluid
- Being tested
- Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
Phase contrast magnetic resonance imaging technique
| Study group | Role | What they receive |
|---|---|---|
| study group | patients with congenital and acquired disorders that can alter the CSF dynamics will undergo phase-contrast magnetic resonance imaging Receives: Device: Magnetic Resonance Imaging | |
| control group | age matched healthy individuals will undergo phase-contrast magnetic resonance imaging Receives: Device: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To calculate different cerebrospinal fluid flow parameters at different levels of flow quantification.
measure Systolic stroke volume and Peak systolic velocity at different levels of flow quantification
Measured: base line
Secondary outcomes (1)
To correlate these parameters to the normal values of age matched control group
correlate Systolic stroke volume and Peak systolic velocity with normal values
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start25 Mar 2019
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebrospinal FluidStudies of the same condition, open and under way.
- More trials run by Assiut 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-control
- Time perspective
- Prospective
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Hassanien Hassanien Bakr, Assiut University
- Investigators
- Shimaa Bakr, MSc, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656016
- Sponsor's protocol ID
- CSFFPCMRI
- Status last verified
- Jan 2024
- First submitted
- 29 Aug 2018
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sakka L, Coll G, Chazal J. Anatomy and physiology of cerebrospinal fluid. Eur Ann Otorhinolaryngol Head Neck Dis. 2011 Dec;128(6):309-16. doi: 10.1016/j.anorl.2011.03.002. Epub 2011 Nov 18.
PubMed 22100360Yildiz H, Yazici Z, Hakyemez B, Erdogan C, Parlak M. Evaluation of CSF flow patterns of posterior fossa cystic malformations using CSF flow MR imaging. Neuroradiology. 2006 Sep;48(9):595-605. doi: 10.1007/s00234-006-0098-8. Epub 2006 Jun 3.
PubMed 16752134Yamada S, Tsuchiya K, Bradley WG, Law M, Winkler ML, Borzage MT, Miyazaki M, Kelly EJ, McComb JG. Current and emerging MR imaging techniques for the diagnosis and management of CSF flow disorders: a review of phase-contrast and time-spatial labeling inversion pulse. AJNR Am J Neuroradiol. 2015 Apr;36(4):623-30. doi: 10.3174/ajnr.A4030. Epub 2014 Jul 10.
PubMed 25012672Parkkola RK, Komu ME, Aarimaa TM, Alanen MS, Thomsen C. Cerebrospinal fluid flow in children with normal and dilated ventricles studied by MR imaging. Acta Radiol. 2001 Jan;42(1):33-8. doi: 10.1080/028418501127346431.
PubMed 11167329Ng SE, Low AM, Tang KK, Lim WE, Kwok RK. Idiopathic normal pressure hydrocephalus: correlating magnetic resonance imaging biomarkers with clinical response. Ann Acad Med Singap. 2009 Sep;38(9):803-8.
PubMed 19816640
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cerebrospinal Fluid Flow Related Disorders Using a Phase-contrast Magnetic Resonance Imaging Technique.
- ClinicalTrials.gov ID
- NCT03656016
- Acronym / sponsor ID
- CSFFPCMRI
- Conditions
- Cerebrospinal Fluid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 4 Sep 2018 (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.
Cerebrospinal fluid is a clear, colorless fluid that circulates in the cranial and spinal subarachnoid spaces, located between the pia and arachnoid matters. It is mainly produced by the choroid plexus, while lesser amount produced by the ependymal cells lining the ventricles. Its function includes cushioning and lubrication of the central nervous system, circulation of nutrients and waste collection providing basic mechanical and immunological protection to the brain.
Detailed description
There are several disorders such as communicating and non- communicating hydrocephalus, normal pressure hydrocephalus, cystic cerebrospinal fluid collections, Chiari malformation, syringomyelic cyst and arachnoid cyst that can change the cerebrospinal fluid dynamics.
Rapid advances in imaging techniques have remarkably improved the diagnosis and treatment of these disorders.
Phase contrast magnetic resonance imaging is a rapid, simple and non-invasive technique which is sensitive to even small cerebrospinal fluid flows, and can be used to evaluate cerebrospinal fluid flow both qualitatively and quantitatively. Cine phase contrast magnetic resonance images show cerebrospinal fluid flow in a dynamic, more easily appreciable, and in a more pleasing manner, allowing the delineation of obstruction, if present, along the portions of cerebrospinal fluid pathway where obstruction is common.
Phase contrast magnetic resonance imaging can be used to discriminate between communicating hydrocephalus and non-communicating hydrocephalus, to localize the level of obstruction in obstructive hydrocephalus, to determine whether arachnoid cysts communicate with the subarachnoid space, to differentiate between arachnoid cysts and subarachnoid space, to discriminate between syringomyelia and cystic myelomalacia, and to evaluate flow patterns of posterior fossa cystic malformations.
This imaging method can also provide significant information in pre-operative evaluation of Chiari 1 malformation and post-operative follow-up of patients with neuroendoscopic third ventriculostomy and ventriculoperitoneal shunt.
The application of cine phase contrast magnetic resonance imaging technique in patients with normal pressure hydrocephalus holds great promise for improvement of the diagnosis, especially in those cases where the differentiation from atrophy on clinical and conventional radiological basis is difficult.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Device: Magnetic Resonance Imagingpatients with congenital and acquired disorders that can alter the CSF dynamics will undergo phase-contrast magnetic resonance imaging |
| control group | – | Device: Magnetic Resonance Imagingage matched healthy individuals will undergo phase-contrast magnetic resonance imaging |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with different age groups and both sex with clinical and routine conventional magnetic resonance imaging findings suggestive of cerebrospinal fluid flow disorders
Key inclusion criteria (1 listed)
- Patients with different age groups and both sex with clinical and routine conventional magnetic resonance imaging findings suggestive of cerebrospinal fluid flow disorders.
Key exclusion criteria (3 listed)
- Patients with contraindications for MRI, e.g. an implanted magnetic device, pacemakers or claustrophobia.
- Patients with VP shunts
- Patients with ventriculomegally due to brain SOLs.
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 ImagingPhase contrast magnetic resonance imaging technique | Device | control group, study group |
Primary outcome
To calculate different cerebrospinal fluid flow parameters at different levels of flow quantification.
Time frame: base line
measure Systolic stroke volume and Peak systolic velocity at different levels of flow quantification
1 secondary outcome
To correlate these parameters to the normal values of age matched control group
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 22100360Sakka L, Coll G, Chazal J. Anatomy and physiology of cerebrospinal fluid. Eur Ann Otorhinolaryngol Head Neck Dis. 2011 Dec;128(6):309-16. doi: 10.1016/j.anorl.2011.03.002. Epub 2011 Nov 18.
- Background: PubMed 16752134Yildiz H, Yazici Z, Hakyemez B, Erdogan C, Parlak M. Evaluation of CSF flow patterns of posterior fossa cystic malformations using CSF flow MR imaging. Neuroradiology. 2006 Sep;48(9):595-605. doi: 10.1007/s00234-006-0098-8. Epub 2006 Jun 3.
- Background: PubMed 25012672Yamada S, Tsuchiya K, Bradley WG, Law M, Winkler ML, Borzage MT, Miyazaki M, Kelly EJ, McComb JG. Current and emerging MR imaging techniques for the diagnosis and management of CSF flow disorders: a review of phase-contrast and time-spatial labeling inversion pulse. AJNR Am J Neuroradiol. 2015 Apr;36(4):623-30. doi: 10.3174/ajnr.A4030. Epub 2014 Jul 10.
- Background: PubMed 11167329Parkkola RK, Komu ME, Aarimaa TM, Alanen MS, Thomsen C. Cerebrospinal fluid flow in children with normal and dilated ventricles studied by MR imaging. Acta Radiol. 2001 Jan;42(1):33-8. doi: 10.1080/028418501127346431.
- Background: PubMed 19816640Ng SE, Low AM, Tang KK, Lim WE, Kwok RK. Idiopathic normal pressure hydrocephalus: correlating magnetic resonance imaging biomarkers with clinical response. Ann Acad Med Singap. 2009 Sep;38(9):803-8.
- Individual participant dataSharing planned: Undecided
Related trials for Cerebrospinal Fluid
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 1
A Study of LY3439539 in Participants With Alzheimer's Disease
Alzheimer Disease
Not yet recruitingObservational study
Multimodal MRI Assessment of Brain Fluid Circulation in Idiopathic Intracranial Hypertension
Idiopathic Intracranial Hypertension
Recruiting
Investigation of the Delve Detect Cerebrospinal Fluid (CSF) Metagenomic Next-generation Sequencing (mNGS) Test When Used for the Initial Diagnostic Workup of Patients With Suspected Central Nervous System (CNS) Infection
Central Nervous System Infection
RecruitingObservational study
Cerebrospinal Fluid Biomarkers of Myotonic Dystrophy
Myotonic Dystrophy Type 1
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.
Shimaa Bakr, MSc principal investigator
Assiut University
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 Cerebrospinal Fluid, run by Assiut 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 3 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 20 Nov 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 Mostafa Hussein (01122999878, thabet.mostafa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To calculate different cerebrospinal fluid flow parameters at different levels of flow quantification. (time frame: base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03656016, which also lists 5 linked publications.
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 20 Nov 2024.