GADOBUTROL for Idiopathic normal pressure hydrocephalus (INPH) | Cerebrospinal fluid circulation disorder

Inclusion criteria

• {"criterion_text":"- Patients investigated for suspected idiopathic normal pressure hydrocephalus at Umeå University hospital"}

Exclusion criteria

• {"criterion_text":"- Age < 65"}
• {"criterion_text":"- known contradicting allergies"}
• {"criterion_text":"- Known contraindications for magnetic reconance imaging"}
• {"criterion_text":"- Renal impairment (as deffined by blood test at admission)"}
• {"criterion_text":"- Current treatment with anticoagulation medication"}
• {"criterion_text":"- Low threshold for seizures"}
• {"criterion_text":"- History of bronchial asthma"}
• {"criterion_text":"- Previous investigation with gadolinium contrast medium"}
• {"criterion_text":"- Mini mental state examination (MMS) < 20"}
• {"criterion_text":"- Not able to understand instructions needed for informed concent"}

Primary endpoints

• {"endpoint_text":"- Time-dependent change in signal intensity on brain MRI after intrathecal contrast administration will be analyzed with indicator dilution algorthim that will be optimized using computational fluid dynamic simulations.","definition_or_measurement_approach":"Analysis of time-dependent change in MRI signal intensity after intrathecal Gadovist using an indicator dilution algorithm optimized with computational fluid dynamic simulations."}
• {"endpoint_text":"- Registration of possible adverse events related to the intrathecal injection of Gadovist","definition_or_measurement_approach":"Recording/registration of any adverse events related to the intrathecal injection of Gadovist."}

Secondary endpoints

• {"endpoint_text":"- Comparision 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.","definition_or_measurement_approach":"Comparison of contrast distribution with other MRI sequences and CSF dynamic parameters to investigate driving mechanisms of distribution."}
• {"endpoint_text":"- Quantified pre-operative glymphatic function will be correlated to clinical improvment after CSF shunting of INPH patients","definition_or_measurement_approach":"Correlation analysis between quantified pre-operative glymphatic function and clinical improvement after CSF shunting in INPH patients."}

Sweden

Earliest CTIS Part Ii Submission Date

11-12-2024

Latest Decision Or Authorization Date

13-01-2025

Processing Time Days

33

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Region Vaesterbotten

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden