Intrathecal contrast-enhanced MRI for investigation of cerebrospinal fluid transportation
interventional
N/A
1 country
1
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 events related to the administration of Gadovist
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 17, 2024
Actual (reported)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.
Registration of possible adverse events related to the intrathecal injection of Gadovist
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.
Quantified pre-operative glymphatic function will be correlated to clinical improvment after CSF shunting of INPH patients
Quantified pre-operative glymphatic function will be correlated to clinical progress and beta-amyloid content in HC and AD-patients.
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These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
VIZAMYL 400 MBq/mL solution for injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
Gadovist 1.0 mmol/ml solution for injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
VIZAMYL 400 MBq/mL solution for injection
Named ingredient: Flutemetamol (18f)
View registry recordGadovist 1.0 mmol/ml solution for injection
Named ingredient: gadobutrol
View registry recordRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Region Vaesterbotten
Umea, 901 85, Sweden
Prof Malm, Department of neurology
First Submitted
December 17, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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