Water absorption in brain of hydrocephalus

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oslo University Hospital HF

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Nervous System Diseases [C10]

Trial duration

29 Jan 2025 → ongoing

Decision date (initial)

2025-01-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Oslo university hospital

External identifiers

EU CT number

2024-519933-53-00

EudraCT number

2022-002094-29

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

Individualized determination of ventricular water absorption capacity in patients with hydrocephalus

Secondary objectives 6

1. Establish a pharmacokinetic model for ventricular water absorption in communicating and non-communicating hydrocephalus in order to identify shunt-dependent individuals.
2. Establish imaging information about water absorption from ventricles using PET.
3. Establish the safety and tolerability of the method of ventricular 15-oxygen-water infusion testing in hydrocephalus patients.
4. Compare CSF molecular profile with ventricular water absorption capacity.
5. Quantify cerebral blood flow (CBF) using intravenous 15-oxygen-water PET/CT.
6. Explore whether parameters derived from intravenous 15-oxygen-water PET correspond to those derived from intraventricular 15-oxygen-water administration, with the aim of assessing whether the intravenous route may serve as a less invasive surrogate in future studies.

Conditions and MedDRA coding

Adult hydrocephalus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Adult patients with communicating hydrocephalus
2. Adult patients with non-communicating hydrocephalus

Exclusion criteria 4

1. Patients with impaired ability to consent.
2. Patients < 18 years of age or >80 years of age.
3. Pregnant women or women who are breastfeeding.
4. Consider pregnancy testing in woman in fertile age.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. From venous blood-samples during ventricular 15-oxygen-water infusion testing establish population pharmacokinetic measures of ventricular water absorption capacity on the individual basis. These measures include time to peak concentration, maximum concentration, area under curve and half time to 50% clearance.

Secondary endpoints 4

1. Image ventricular water absorption to brain using positron emission tomography (PET) imaging in communicating and non-communicating hydrocephalus.
2. Quantify cerebral blood flow using intravenous 15-oxygen-water PET/CT.
3. Compare water-exchange parameters obtained from intravenous and intraventricular 15-oxygen-water administration.
4. Establish the safety and tolerability of the method, including adverse events related to the additional intravenous PET/CT procedure and arterial blood sampling.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

Sponsor organisation

Oslo University Hospital HF

Address

Taarnbygget, Kirkeveien 166 Kirkeveien 166

City

Oslo

Postcode

0450

Country

Norway

Scientific contact point

Organisation

Oslo University Hospital HF

Contact name

Per Kristian Eide

Public contact point

Organisation

Oslo University Hospital HF

Contact name

Per Kristian Eide

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications