MRI contrast agent in the spinal canal of adults with cerebrospinal fluid circulation disorders
- Conditions
- Cerebrospinal fluid circulation disorder seen in the following clinical disease states: Communicating hydrocephalus, idiopathic intracranial hypertension, idiopathic intracranial hypotension, intracranial cysts (cerebral cysts and arachnoid cysts).Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-001673-40-NO
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients between 18 and 80 years of age.
Patients who are assessed for the following clinical states:
- Communicating hydrocephalus,
- Idiopathic intracranial hypertension,
- Idiopathic intracranial hypotension,
- Intracranial cysts (cerebral cysts and arachnoid cysts).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
Exclusion Criteria
- Patients with contrast allergy
- Patients with renal failure.
- Patients < 18 years of age, or >80 years of age.
- Pregnant women, or women who are breastfeeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine distribution of contrast agent as assessed by repeated cranial MRI.;Secondary Objective: Compare site of blockade of cerebrospinal fluid circulation in different disease states.;Primary end point(s): Time-dependent appearance and disappearance of contrast agent in brain, as revealed by repetitive MRI, following intrathecal administration.<br>A contrast-clearance curve is created for each individual patient.;Timepoint(s) of evaluation of this end point: After a single intrathecal injection of contrast agent, MRI is done after 0-2 hours, and after 4, 6, 8, and 24 hours.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Differences in distribution of contrast agent between patients with different kinds of CSF circulation disturbance.;Timepoint(s) of evaluation of this end point: After a single intrathecal injection of contrast agent, MRI is done after 0-2 hours, and after 4, 6, 8, and 24 hours.