Cerebral Haemorrhage associated Inflammation: a PET/MRI Study

Conditions: Intracerebral hemorrhage

Registration Number: NL-OMON29665

Lead Sponsor: Radboudumc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

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 or other known underlying lesion;
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 (see appendix A );
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 non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is perihematomal oedema on MRI at day 7±1, which will be correlated with perihematomal uptake of 18F-DPA-714 on PET imaging at day 3±1 as a measure of neuroinflammation.

Secondary Outcome Measures

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