Brain metastases metastatic brain disease
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For patients: - Age >= 18 years; - Expected survival >= 5 months, as determined by Graded Prognostic Assessment (GPA) score; - Either radiographic and/or histologic proof of metastatic brain disease eligible for cranial irradiation; - Eligible for brain irradiation for prophylaxis or treatment; - Signed informed consent; - Sufficient knowledge of the Dutch language to allow reliable use of the standardized tests and understand the study information; - Participation in the COIMBRA cohort, with given consent for filling in QoL questionnaires. For healthy volunteers: - Age >= 18 years; - Signed informed consent; - Sufficient knowledge of the Dutch language to understand the study information.
Exclusion criteria
Exclusion criteria: For patients and healthy volunteers: - Unwilling or unable to cooperate with breathing manoeuvres or keeping still; - Medical contraindications to limited hypercapnia (known metabolic acidosis or alkalosis); - Standard contraindications for 3T MRI scanning; - Standard contraindications for using the RespirAct RA-MRTM MRI UNIT; - Noncompliance with prescribed anti-seizure medication; - Severe current neurological or psychiatric diseases (including pre-existent dementia or other cognitive disorders as diagnosed by a neurologist, psychiatrist or gerontologist), not related to the primary malignancy or cerebral metastases; - History of cerebrovascular disease (ischaemic stroke or intracranial haemorrhage); - Non-prophylactic use of >4 mg dexamethasone on the day of the cerebrovascular stress test; - Cardiovascular disease: congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, and myocardial infarction within past 6 months as diagnosed by a cardiologist; - Pulmonary disease as diagnosed by a pulmonologist: oxygen dependency at rest or with exercise, restrictive lung disease with resting respiratory rate over 15 breaths/min; - Concurrent severe or uncontrolled medical disease (e.g., active systemic infection); - History of bleomycin treatment; - Body weight 100 kg; - Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoints will be the change in neurocognitive test score between pre- and post-radiotherapy in relation to cerebrovascular reactivity as measured with MRI before the start of radiation treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The changes in cerebral hemodynamics (CVR and cerebral blood perfusion) in relation to the changes in cognitive performance 3 months after radiotherapy. 2. The spatial distribution of cerebral hemodynamics in relation to change in cerebral hemodynamics 3 months after radiotherapy. 3. The spatial relationship between dose distribution and regional cerebral hemodynamics changes 3 months after radiotherapy. 4. The spatial relationship between dose distribution and cerebral morphological changes 3 months after radiotherapy. 5. Relation between patient reported QoL and performance on the NCA both before and 3 and 11 months after radiotherapy. 6. Relation between changes in brain morphology (e.g. cortical thickness or white matter tract integrity) and changes in cerebral hemodynamics and cognitive performance. 7. Comparison of the WBRT and SRS group regarding cognitive performance and cerebral hemodynamics. 8. Relation of compliance with both the CST and NCA in patients receiving radiotherapy. | — |
Countries
Netherlands
Outcome results
None listed