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Cerebral Haemorrhage associated Inflammation: a PET/MRI Study

Cerebral Haemorrhage associated Inflammation: a PET/MRI Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29665
Enrollment
10
Registered
2020-08-13
Start date
2020-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral hemorrhage

Interventions

None listed

Sponsors

Radboudumc
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactMaaike Cliteur

Radboudumc Nijmegen

maaike.cliteur@radboudumc.nl0650155723

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)