MRI contrast agent in the spinal canal to investigate transportation of the cerebrospinal fluid in the brain.

Intrathecal contrast-enhanced MRI for investigation of cerebrospinal fluid transportation - 2020/11 Intrathecal MRI-contrast

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005542-42-SE

Enrollment

Registered

2021-01-25

Start date

2021-03-11

Completion date

Unknown

Last updated

2025-01-27

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 clinically suspected idiopathic normal pressure hydrocephalus

Interventions

Trade Name: Gadovist Pharmaceutical Form: Solution for injection INN or Proposed INN: Gadobutrol CAS Number: 138071-82-6 Other descriptive name: GADOBUTROL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients investigated for suspected idiopathic normal pressure hydrocephalus at Umeå University Hospital 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Age < 65 Known contradicting allergies Known contraindications for magnetic resonance imaging Renal impairment (as deffined by blood test at admission) Current treatment with anticoagulation medication Low threshold to seizures History of bronchial asthma Previous investigation with gadolinium contrast medium Mini Mental State Examination (MMSE) <18 Not able to understand instructions needed for informed concent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To quantify the distribution and rate of elimination of the contrast agent as assessed by repeated MRI in humans. We will also document any adverse avents related to the administration of Gadovist;Secondary Objective: To investigate the driving mechanism of the flow and if the quantified glymphatic function can be used to predict which INPH patients that will be improved by shunting with CSF shunt. ;Primary end point(s): Time-dependent change in signal intensity on brain MRI after intrathecal contrast administration will be analyzed with an indicator dilution algorithm that will be optimized using computational fluid dynamic simulations. Registration of possible adverse events related to the intrathecal injection of Gadovist.;Timepoint(s) of evaluation of this end point: After the single intrathecal injection of the contrast agent, MRI will be done at approximatly 4 time-points within 24 hours post injection. Advers events will be registered during the first 24h post injection and during follow up.	—

Measure

Time frame

Main Objective: To quantify the distribution and rate of elimination of the contrast agent as assessed by repeated MRI in humans. We will also document any adverse avents related to the administration of Gadovist;Secondary Objective: To investigate the driving mechanism of the flow and if the quantified glymphatic function can be used to predict which INPH patients that will be improved by shunting with CSF shunt. ;Primary end point(s): Time-dependent change in signal intensity on brain MRI after intrathecal contrast administration will be analyzed with an indicator dilution algorithm that will be optimized using computational fluid dynamic simulations. Registration of possible adverse events related to the intrathecal injection of Gadovist.;Timepoint(s) of evaluation of this end point: After the single intrathecal injection of the contrast agent, MRI will be done at approximatly 4 time-points within 24 hours post injection. Advers events will be registered during the first 24h post injection and during follow up.

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Secondary

Measure	Time frame
Secondary end point(s): Comparison between the distribution of the contrast and other MRI-sequences and cerebrospinal fluid dynamic parameters which provides us with information regarding possible driving mechanisms for the distribution. Quantified pre-operative glymphatic function will be correlated to clinical improvement after CSF shunting of INPH patients.;Timepoint(s) of evaluation of this end point: Cerebrospinal fluid dynamic data will be gathered in conjunction with the injection of the contrast agent. The other MRI-sequences will be done at the different time-points discribed in E.5.1.1 as well as in separate scans not involving an injection of a contrast agent. Clinical improvement will be accessed 3 months after surgery.	—

Measure

Time frame

Secondary end point(s): Comparison between the distribution of the contrast and other MRI-sequences and cerebrospinal fluid dynamic parameters which provides us with information regarding possible driving mechanisms for the distribution. Quantified pre-operative glymphatic function will be correlated to clinical improvement after CSF shunting of INPH patients.;Timepoint(s) of evaluation of this end point: Cerebrospinal fluid dynamic data will be gathered in conjunction with the injection of the contrast agent. The other MRI-sequences will be done at the different time-points discribed in E.5.1.1 as well as in separate scans not involving an injection of a contrast agent. Clinical improvement will be accessed 3 months after surgery.

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Countries

Sweden

Contacts

Public ContactProf Malm, Department of Neurology

Region Västerbotten

jan.malm@umu.se00460907850000

Outcome results

None listed

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