The primary objective is to explore changes in cerebrovascular reactivity and tissue oxygenation prior to and after high-grade glioma resection, and before and after (chemo)radiation using 7T MRI by respiratory challenges which induce hypercapnic…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Postoperative ischemia in brain tissue surrounding the resection cavity in
glioma patients is a common complication occurring in two-thirds of patients.
It can lead to neurological deficits, mostly temporary, but sometimes lasting.
The precise cause of postoperative ischemia is not yet known, however, a
disturbed vascular reactivity following the resection is suspected to be
(partly) responsible. Assessment of vascular reactivity and tissue oxygenation
by 7T MR imaging pre-operatively might predict occurrence of ischemia.
Furthermore, vascular reactivity in the postoperative period can be measured to
investigate the effects of glioma treatment, notably in the context of
postoperative ischemia and post-radiation necrosis.
Study objective
The primary objective is to explore changes in cerebrovascular reactivity and
tissue oxygenation prior to and after high-grade glioma resection, and before
and after (chemo)radiation using 7T MRI by respiratory challenges which induce
hypercapnic and hyperoxic conditions in glioma patients.
Study design
This prospective study will measure alterations in cerebrovascular reactivity
prior to and after tumour resection, and before and after (chemo)radiation
using respiratory challenges during measurements at 7T MRI in glioma patients.
Study burden and risks
The controlled gas breathing requires a closed breathing system via a mask,
which can lead to feelings of discomfort or anxiety. Furthermore, hypercapnia
can induce an increased breathing rate due to the chemo-reflex response. Glioma
patients are more prone to increases intracranial pressure (ICP) due to the
intracranial tumour, and therefore the preoperative experiment in particular
may mimic symptoms associated with an increased ICP such as headache or nausea.
Nevertheless, increases in arterial CO2 pressure will remain well within
physiological ranges experienced repeatedly by most people over the course of a
normal day. Furthermore, anaesthetic data show similar increases in CO2
pressure in this population while under (local) anaesthesia for resection.
The Respiract is a medical device that consists of a) a gas blender, b) gas
concentration analysers and c) a computer containing software to output
instructions to the gas blender and monitor results of the gas concentration
analysers. The Respiract can be reset, switching to 100% oxygen, and patients
can notify the research team in case of any discomfort. Additionally, CO2, O2,
breathing frequency and oxygen saturation are monitored non-invasively. No
risks are known for undergoing an MRI. The enclosed space of the MRI can lead
to discomfort or claustrophobia. Subjects will not benefit from the respiratory
challenges or MRI experiments. Four visits of approximately 1.5 hours will be
required for this imaging study.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65195.041.18 |