Clinical trial • Not applicable • Neurology|Other

O15-WATER for Hydrocephalus|Communicating hydrocephalus|Non-communicating hydrocephalus

Not applicable trial of O15-WATER for Hydrocephalus|Communicating hydrocephalus|Non-communicating hydrocephalus. 100 participants.

Overview

Trial Therapeutic Area
Neurology|Other
Trial Disease
Hydrocephalus|Communicating hydrocephalus|Non-communicating hydrocephalus
Trial Stage
Not applicable
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
29-01-2025
First CTIS Authorization Date
29-01-2025

Trial design

Not applicable trial in Norway.

Target Sample Size
100

Eligibility

Recruits 100 Vulnerable population not selected; patients with impaired ability to consent are explicitly excluded ("Patients with impaired ability to consent."). Consent to be provided by the adult participant; no paediatric assent/consent procedures described..

Pregnancy Exclusion
Pregnant women or women who are breastfeeding.
Vulnerable Population
Vulnerable population not selected; patients with impaired ability to consent are explicitly excluded ("Patients with impaired ability to consent."). Consent to be provided by the adult participant; no paediatric assent/consent procedures described.

Inclusion criteria

  • {"criterion_text":"- Adult patients with communicating hydrocephalus"}
  • {"criterion_text":"- Adult patients with non-communicating hydrocephalus"}

Exclusion criteria

  • {"criterion_text":"- Patients with impaired ability to consent."}
  • {"criterion_text":"- Patients < 18 years of age or >80 years of age."}
  • {"criterion_text":"- Pregnant women or women who are breastfeeding."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- From venous blood-samples during ventricular 15-oxygen-water infusion testing establish population pharmacokinetic measures of ventricular water absorption capacity on the individual basis.","definition_or_measurement_approach":"Measured from venous blood samples during ventricular 15-oxygen-water infusion testing; analysed using population pharmacokinetic methods to determine individual ventricular water absorption capacity."}

Secondary endpoints

  • {"endpoint_text":"- Image the ventricular water absorption to brain using positron emission tomography (PET) imaging. for communicating and non-communicating hydrocephalus. Endpoints of safety and tolerability are defined as increase in intracranial pressure and symptoms of intracranial hypertension","definition_or_measurement_approach":"Ventricular water absorption imaged using PET; safety/tolerability endpoints measured as increases in intracranial pressure and occurrence of symptoms of intracranial hypertension."}

Recruitment

Planned Sample Size
100
Recruitment Window Months
91
Consent Approach
Informed consent to be provided by adult participants; patients with impaired ability to consent are excluded. Subject information and informed consent forms are listed among trial documents (multiple versions). No paediatric consent/assent or specific language details provided in the record.

Geography

Total Number Of Sites
1
Total Number Of Participants
100

Norway

Earliest CTIS Part Ii Submission Date
07-12-2024
Latest Decision Or Authorization Date
28-09-2025
Processing Time Days
295
Number Of Sites
1
Number Of Participants
100

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
Number Of Participants
100

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
Water (15O)
Active Substance
O15-WATER
Modality
Radiopharmaceutical
Routes Of Administration
INTRACEREBROVENTRICULAR (ICV)
Route
INTRACEREBROVENTRICULAR (ICV)
Maximum Dose
10 ml

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