Assessing and Predicting Radiation Influence on Cognitive Outcome using the cerebrovascular stress Test

Recruiting

• Conditions: Brain metastases; metastatic brain disease; 10029211

• Registration Number: NL-OMON52427
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 145

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

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 <30 kg, >100 kg;
- Pregnancy.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoints will be the change in neurocognitive test score between pre-<br /><br>and post-radiotherapy in relation to cerebrovascular reactivity as measured<br /><br>with MRI before the start of radiation treatment. </p><br>