Clinical trial • Neurology

gadobutrol for Cerebrospinal fluid disorders|Cognitive impairment|Central nervous system neoplasm|Hydrocephalus|Fatigue

Clinical trial of gadobutrol for Cerebrospinal fluid disorders|Cognitive impairment|Central nervous system neoplasm|Hydrocephalus|Fatigue.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Cerebrospinal fluid disorders|Cognitive impairment|Central nervous system neoplasm|Hydrocephalus|Fatigue
Drug Modality
Diagnostic agent

Key dates

Initial CTIS Submission Date
08-12-2024
First CTIS Authorization Date
28-01-2025

Trial design

Clinical trial across 1 site in Norway.

Target Sample Size
1000

Eligibility

Recruits 1000 Vulnerable population not selected (isVulnerablePopulationSelected: false). Subject information and informed consent form documents are provided (L1_SIS-ICF documents listed). No specific consent or assent procedures for vulnerable populations are described in the available data..

Pregnancy Exclusion
Pregnant women
Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected: false). Subject information and informed consent form documents are provided (L1_SIS-ICF documents listed). No specific consent or assent procedures for vulnerable populations are described in the available data.

Inclusion criteria

  • {"criterion_text":"- Individuals with cerebral symptoms (including cognitive impairment and fatigue)."}
  • {"criterion_text":"- Individuals with imaging evidence of neurological disease (CSF disorders, hydrocephalus, neoplasia in central nervous system)."}
  • {"criterion_text":"- Individuals who receive medical treatment intended to treat the CNS (patients receiving intrathecal chemotherapeutic drugs to prevent tumor spread)."}

Exclusion criteria

  • {"criterion_text":"- Contrast allergy"}
  • {"criterion_text":"- Renal failure"}
  • {"criterion_text":"- < 18 years of age or >80 years of age"}
  • {"criterion_text":"- Pregnant women"}
  • {"criterion_text":"- Women who are breastfeeding"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- MRI evidence of CSF flow Blood-based determination of CSF clearance","definition_or_measurement_approach":"MRI imaging evidence of CSF flow; blood-based determination of CSF clearance"}

Secondary endpoints

  • {"endpoint_text":"- Quantitative estimation of CSF flow and clearance","definition_or_measurement_approach":"Quantitative estimation of CSF flow and clearance (no further measurement details provided)"}

Recruitment

Planned Sample Size
1000
Recruitment Window Months
183
Consent Approach
Subject information and informed consent form documents are provided (L1_SIS-ICF versions listed in documents). No further details on the consent/assent process or languages are provided in the available data.

Geography

Total Number Of Sites
1
Total Number Of Participants
1000

Norway

Earliest CTIS Part Ii Submission Date
02-01-2025
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
448
Number Of Sites
1
Number Of Participants
1000

Sites

Site Name
Oslo University Hospital HF
Department Name
Neurosurgery
Principal Investigator Name
Per Kristian Eide
Principal Investigator Email
p.k.eide@medisin.uio.no
Contact Person Name
Per Kristian Eide
Contact Person Email
p.k.eide@medisin.uio.no

Sponsor

Primary sponsor

Full Name
Oslo University Hospital HF
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Norway

Third parties

  • {"country":"Norway","full_name":"Oslo University Hospital HF","duties_or_roles":"sponsorDuties code: 5","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
GADOBUTROL
Active Substance
gadobutrol
Modality
Diagnostic agent
Routes Of Administration
INTRATHECAL USE
Route
Intrathecal
Starting Dose
0.50 mmol
Maximum Dose
0.50 mmol

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