No registrations found.
ID
Source
Brief title
Health condition
Unruptured intracranial aneurysm
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prediction of inflammation by 18F-IL2 PET-CTA, related to the gold standard of histopathological examination (proof-of-concept).
Secondary outcome
Blinded analysis of interobserver variability in 18F-IL2 PET-CTA interpretation.
Study objective
T-cell inflammation in the vascular wall of an asymptomatic intracranial aneurysm can be accurately detected with 18F-IL2 PET-CTA (proof-of-concept).
Study design
None
Intervention
18F-IL2 PET-CTA
Inclusion criteria
- Age > 18 year
- Presence of an unruptured intracranial aneurysm
- Standard of care decision to treat the aneurysm
- The aneurysm is surgically accessible
- Aneurysm wall sampling is deemed possible by the surgeon
- Written informed consent
Exclusion criteria
- Prior therapy on the targeted unruptured intracranial aneurysm
- Presence of intracranial neurovascular disorders, other than intracranial aneurysms
- Contra-indications to general anesthesia or craniotomy
o Thrombocytopenia (<100,000/µL)
o Uncorrectable coagulopathy (INR >1.5)
- Contra-indications to 18F-IL2 PET-CTA
o Technical impairments to perform the study
Incapacity to lie still for 30 minutes
Physical restrictions, e.g. morbid obesity
Claustrophobia
o Pregnancy or lactation
o Renal insufficiency (estimated glomerular filtration rate < 60 ml/min/1.73 m2)
o Known allergy to iodine contrast agent
o Treatment with metformine
o Morbus Kahler / M. Waldenstrom
o Myasthenia gravis
o Pheochromocytoma
o Mastocytosis
o Thyroid cancer
o Planned thyroid scan
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4922 |
| NTR-old | NTR5024 |
| Other | 201500130 : UMCG |