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CREATIV 2.0

Cerebrovascular Reactivity Evaluation Around glioma Treatment using Imaging of Vessels 2.0 - CREATIV 2.0

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58370
Enrollment
10
Registered
2025-07-22
Start date
2025-12-16
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glioma-related postoperative ischemia Stroke after brain tumor surgery

Interventions

Three moments at which the patient will be scanned at the MRI 7T scanner with the use of the Respiract system (research instrument used to precisely control and monitor the levels of carbon dioxide (C

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: ? Suspected to have a high-grade glioma, for which surgical resection (=20% of enhancing tumour) is planned  ? 18 years or older ? Karnofsky performance status of at least 70 during all timepoints? Ability to give written informed consent

Exclusion criteria

Exclusion criteria: ? History of vascular brain disease (stroke, moya-moya, aneurysm) ? Prior cerebral surgery or radiation ? Signs of obstructive hydrocephalus on diagnostic MRI or clinical indication of blockage of CSF outflow from the brain ? Symptoms of increased intracranial pressure (headache, nausea, blurred vision) even under dexamethasone ? Non-compliance with prescribed anti-seizure medication ? CNS haemorrhage of Grade > 1 on baseline MRI scan, unless subsequently documented to have resolved ? Any known metastatic extracranial or leptomeningeal disease ? Multifocal disease ? Pregnancy In addition, a potential subject who meets any of the following criteria prior to inclusion or any scan will be excluded from (further) participation in this study: ? Clinical signs of increased intracranial pressure even under dexamethasone ? Unwilling or unable to co-operate with breathing manoeuvres ? Respiratory or cardiac limitations to breathing at 20 L/min ? Medical contra-indications to limited hypercapnia (known metabolic acidosis or alkalosis) ? Standard contraindications for 7T MRI scanning, according to MRI guidelines.? Resting PetCO2 level is measured above 50 mmHg with the RespirAct before testing outside of the scanner.

Design outcomes

Primary

MeasureTime frame
The main endpoints will be CVR (%MRI signal change per change in mmHg end-tidal CO2) before and after surgery and 1 month after surgery.

Secondary

MeasureTime frame
The second endpoint: Relationship between alterations in CVR throughout the brain before surgery, after surgery, and at the recovery time-point directly preceding adjuvant treatment (generally 1 month post surgery)

Countries

Netherlands

Contacts

Public ContactA Bhogal

Universitair Medisch Centrum Utrecht

a.bhogal@umcutrecht.nl0887551234

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026