glioma-related postoperative ischemia Stroke after brain tumor surgery
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Universitair Medisch Centrum Utrecht