Cerebral Haemorrhage associated Inflammation: a PET/MRI Study

Completed

Conditions: cerebral hemorrhage
hemorrhagic stroke
10007963

Registration Number: NL-OMON49603

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Age >= 18 years;
2. Supratentorial non-traumatic ICH confirmed by CT, without a confirmed
causative lesion on admission CT-angiography (e.g. aneurysm, AVM, DAVF,
cerebral venous sinus thrombosis) or other known underlying lesion (e.g.
tumour, cavernoma);
3. Minimal haemorrhage volume of 10mL;
4. Inclusion within 24 hours after symptom onset;
5. Patient*s or legal representative*s informed consent.

Exclusion Criteria

1. Severe infection at admission, requiring antibiotic treatment;
2. Use of immunosuppressive or immune-modulating therapy at admission;
3. Pre-stroke modified Rankin Scale score >= 3;
4. Severe ICH, unlikely to survive the first 72 hours (defined as Glasgow Coma
Scale score < 6 at time of consent);
5. Pregnancy or breast-feeding;
6. Standard contraindications to MRI;
7. Administration of a radionuclide within 10 physical half-lives prior to
study enrolment;
8. Known prior allergic reaction to gadolinium contrast or one of the
constituents of its solution for administration;
9. Severe renal impairment (eGFR <30ml/min/1.73m);
10. Planned neurosurgical haematoma evacuation

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is perihematomal oedema (measured as oedema extension distance<br /><br>on MRI at day 7), which will be correlated with perihematomal uptake of<br /><br>18F-DPA-714 on PET imaging at day 3 as a measure of neuroinflammation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are the association between and the perihematomal<br /><br>uptake of 18F-DPA-714 on PET imaging at day 3 and blood barrier leakage Ktrans<br /><br>as measured with DCE-MRI on day 7. Furthermore the correlation with serum<br /><br>inflammation markers (comparing day 1, 3 and 7 to baseline) will be assessed.</p><br>