Cerebrovascular Reactivity Evaluation Around glioma Treatment using Imaging of Vessels

Conditions: brain tumour
Glioma
10029211

Registration Number: NL-OMON55560

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

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

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The CVR and tissue oxygenation measured on MRI with respiratory challenges<br /><br>within 1 week before surgery, within 1 week after surgery, within 2 weeks<br /><br>before (chemo)radiation and within 1 month after (chemo)radiation will be the<br /><br>main endpoints.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Relation of the changes in cerebrovascular reactivity and tissue oxygenation to<br /><br>occurrence and location of postoperative ischemic changes and post-radiation<br /><br>necrosis on routinely acquired clinical MRI scans.</p><br>