Imaging of Active CSF RhinorrheaNCT05801393
HRCT, CT Cisternography and MR Cisternography in Assessment of CSF Rhinorrhea
An observational study of Imaging of Active CSF Rhinorrhea, run by Assiut University.
Trial summary
To assess the diagnostic accuracy of combined high resolution CT, CT cisternography and MR cisternography in pre operative assessment of active CSF leak, compared by endoscopic sinus surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Imaging of Active CSF Rhinorrhea
- What is being tested?
- CT, MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 30 Mar 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
- Child, Adult, Older adult
Study population: 50 patients with active CSF rhinorrhea, no age limits
Who may be able to join
- (1) patients with active traumatic or non traumatic CSF leakage.
- (2) patients with adequate organ function.
Who cannot join
- (1) Patients known to have contrast hypersensitivity. (2) Patients with any general contraindication to MRI as presence of para magnetic substance as pacemakers or with claustrophobia.
- Patients with contraindication to lumbar puncture:
- Infection near the puncture site, fever, sepsis.
- New focal neurological signs or seizures.
- Increased intra cranial tension.
- Space occupying lesion.
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- Vertebral deformity, retropulsion, severe vertebral osteoarthritis or degenerative disc disease renders procedures more technically difficult.
- Coagulopathy.
- Patient refusal.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Combined HRC, CT Cisternography and MR Cisternography in Assessment of Active CSF Rhinorrhes Compared to Operative Findings
To assess the diagnostic accuracy of combined high resolution CT, CT cisternography and MR cisternography in pre operative assessment of active CSF leak, compared by endoscopic sinus surgery.
Read the detailed description
CSF rhinorrhea is defined as passage of CSF from the subarachnoid space through osseous and dural defect at skull base into the nasal cavity.
Causes of CSF rhinorrhea are classified into traumatic (including iatrogenic) and non traumatic (including spontaneous leak).
Patients are presented by variable symptoms including clear nasal discharge, headache or with complications like meningitis or even brain abscess, so closure of the defect is of great importance with required accurate localization of the defect and its dimensions.
CSF rhinorrhea can be also classified into active when with active dripping or inactive when dripping is intermittent.
Different imaging modalities have been employed to localize and characterize skull base defects responsible for CSF leakage including computed tomography (CT), CT cisternography (CTC), magnetic resonance imaging (MRI), MR cisternography (MRC) and radionuclide cisternography (RNC). However, there is still no gold standard imaging modality.
High resolution computed tomography (HRCT) provides accurate bone details, but difficult to differentiate para nasal sinus secretions from CSF leak. contrast enhancing CT cisternography has an advantage of definite proof of CSF leak and definite anatomical localization of the bony defect, but side effects like headache and meningeal irritation may occur.
Magnetic resonance imaging (MRI) with 3D- constructive interference in steady state (3D-CISS) (MR cisternography) instead of the invasive CT cisternography shows CSF as a bright signal without intra thecal contrast injection. Also MRI provides intra cranial details, but it lacks of bony details.
In the present prospective study, we will assess the use of HRCT, CTC and MRC imaging modalities in definite diagnosis and localization of active CSF leak.
- Conditions
- Imaging of Active CSF Rhinorrhea
- Being tested
- CT, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT, MRIRadiation
HRCT with no IV contrast administration and bone algorithm. Intra thecal injection of contrast, then CT in prone position to obtain direct coronal cuts.
MR cisternography using a three dimensional constructive interference in steady state (3D-CISS) sequence.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the diagnostic accuracy of combined high resolution CT, CT cisternography and MR cisternography in pre operative assessment of active CSF leak, compared by endoscopic sinus surgery.
Patients with persistent or intermittent CSF rhinorrhea will be scanned after a full clinical history with Oto-laryngological examination to confirm the presence of CSF leak
Measured: from May 2023 to January 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Imaging of Active CSF RhinorrheaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Abdelsabour Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801393
- Sponsor's protocol ID
- cisternography CSF rhinorrhea
- Status last verified
- Mar 2023
- First submitted
- 25 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined HRC, CT Cisternography and MR Cisternography in Assessment of Active CSF Rhinorrhes Compared to Operative Findings
- ClinicalTrials.gov ID
- NCT05801393
- Acronym / sponsor ID
- cisternography CSF rhinorrhea
- Conditions
- Imaging of Active CSF Rhinorrhea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 6 Apr 2023 (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 diagnostic accuracy of combined high resolution CT, CT cisternography and MR cisternography in pre operative assessment of active CSF leak, compared by endoscopic sinus surgery.
Detailed description
CSF rhinorrhea is defined as passage of CSF from the subarachnoid space through osseous and dural defect at skull base into the nasal cavity.
Causes of CSF rhinorrhea are classified into traumatic (including iatrogenic) and non traumatic (including spontaneous leak).
Patients are presented by variable symptoms including clear nasal discharge, headache or with complications like meningitis or even brain abscess, so closure of the defect is of great importance with required accurate localization of the defect and its dimensions.
CSF rhinorrhea can be also classified into active when with active dripping or inactive when dripping is intermittent.
Different imaging modalities have been employed to localize and characterize skull base defects responsible for CSF leakage including computed tomography (CT), CT cisternography (CTC), magnetic resonance imaging (MRI), MR cisternography (MRC) and radionuclide cisternography (RNC). However, there is still no gold standard imaging modality.
High resolution computed tomography (HRCT) provides accurate bone details, but difficult to differentiate para nasal sinus secretions from CSF leak. contrast enhancing CT cisternography has an advantage of definite proof of CSF leak and definite anatomical localization of the bony defect, but side effects like headache and meningeal irritation may occur.
Magnetic resonance imaging (MRI) with 3D- constructive interference in steady state (3D-CISS) (MR cisternography) instead of the invasive CT cisternography shows CSF as a bright signal without intra thecal contrast injection. Also MRI provides intra cranial details, but it lacks of bony details.
In the present prospective study, we will assess the use of HRCT, CTC and MRC imaging modalities in definite diagnosis and localization of active CSF leak.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 50 patients with active CSF rhinorrhea, no age limits
Key inclusion criteria (2 listed)
- (1) patients with active traumatic or non traumatic CSF leakage.
- (2) patients with adequate organ function.
Key exclusion criteria (9 listed)
- (1) Patients known to have contrast hypersensitivity. (2) Patients with any general contraindication to MRI as presence of para magnetic substance as pacemakers or with claustrophobia.
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 |
|---|---|---|
| CT, MRIHRCT with no IV contrast administration and bone algorithm. Intra thecal injection of contrast, then CT in prone position to obtain direct coronal cuts. MR cisternography using a three dimensional constructive interference in steady state (3D-CISS) sequence. | Radiation | – |
Primary outcome
To assess the diagnostic accuracy of combined high resolution CT, CT cisternography and MR cisternography in pre operative assessment of active CSF leak, compared by endoscopic sinus surgery.
Time frame: from May 2023 to January 2025
Patients with persistent or intermittent CSF rhinorrhea will be scanned after a full clinical history with Oto-laryngological examination to confirm the presence of CSF leak
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Imaging of Active CSF Rhinorrhea, run by Assiut University.
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 2 inclusion and 9 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 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Ghada A Mohamed (01141729468, ae476647@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the diagnostic accuracy of combined high resolution CT, CT cisternography and MR cisternography in pre operative assessment of active CSF leak, compared by endoscopic sinus surgery. (time frame: from May 2023 to January 2025). 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 6 Apr 2023.