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Cerebrovascular Reactivity Evaluation Around glioma Treatment using Imaging of Vessels

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

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55560
Enrollment
10
Registered
2019-01-09
Start date
2022-01-01
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

brain tumour Glioma

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Prior cerebral surgery or radiation History of vascular brain disease 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 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 Postoperative pathology results indicating a lesion other than high-grade glioma

Design outcomes

Primary

MeasureTime frame
The CVR and tissue oxygenation measured on MRI with respiratory challenges within 1 week before surgery, within 1 week after surgery, within 2 weeks before (chemo)radiation and within 1 month after (chemo)radiation will be the main endpoints.

Secondary

MeasureTime frame
Relation of the changes in cerebrovascular reactivity and tissue oxygenation to occurrence and location of postoperative ischemic changes and post-radiation necrosis on routinely acquired clinical MRI scans.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 1, 2026