MRI contrast agent in the spinal canal of adults with cerebrospinal fluid circulation disorders

INTRATHECAL CONTRAST-ENHANCED MAGNETIC RESONANCE IMAGING - 2015/96 Intrathecal MRI-contrast

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001673-40-NO

Enrollment

100

Registered

2015-05-04

Start date

2015-06-29

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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).

Interventions

Trade Name: Gadovist Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - Patients with contrast allergy - Patients with renal failure. - Patients 80 years of age. - Pregnant women, or women who are breastfeeding.

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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

Measure	Time frame
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.	—

Countries

Norway

Contacts

Public ContactProf Eide, Dept of Neurosurgery

Oslo University Hospital

p.k.eide@medisin.uio.no+4723074321

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026