To ascertain the hypothesis that T-cell inflammation in the vascular wall of an unruptured intracranial aneurysm can be accurately detected with 18F-IL2 PET (proof-of-concept).
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Detection of inflammation by 18F-IL2 PET, related to the gold standard
(histopathology/molecular analysis).
Secondary outcome
Analysis of interobserver variability in 18F-IL2 PET interpretation.
Background summary
The University Medical Center Groningen is a tertiary referral center for
neurovascular diseases, e.g. intracranial aneurysms. In the Netherlands, the
prevalence of intracranial aneurysms is estimated between 4 and 6% of the
general population. The vast majority of these aneurysms is asymptomatic, but a
rupture results in a so-called subarachnoid hemorrhage (SAH). An SAH is a
hazardous hemorrhagic stroke that causes severe morbidity and mortality in a
high percentage of the cases. Since the peak incidence of SAH is in middle-aged
people (40-60 years old), the social impact of a ruptured intracranial aneurysm
is much higher than other types of stroke. Thus, although only a minority of
the aneurysms becomes symptomatic, the consequences of a ruptured aneurysm are
so disastrous that there is a great demand for an personalized test that
indicates whether an intracranial aneurysms is prone to become symptomatic or
not. In symptomatic aneurysms it has been shown that inflammation in the
vascular wall, in particular T-cell invasion, plays an important role in the
action of the rupture. The hypothesis is that the probability of rupture (SAH)
can be estimated by screening for T cell inflammation in the vascular wall of
unruptured aneurysms. The T cells can be detected non-invasively by means of
molecular imaging. The specific PET tracer fluorine- 18 labeled interleukin-2
(18F-IL2) is ideal for this purpose. By combining the PET with MR Angiography,
the inflammation can be demonstrated selectively in the vascular wall of an
aneurysm.
Study objective
To ascertain the hypothesis that T-cell inflammation in the vascular wall of an
unruptured intracranial aneurysm can be accurately detected with 18F-IL2 PET
(proof-of-concept).
Study design
Observational (diagnostic) pilot-study.
Study burden and risks
The burden and risks associated with the participation in this study are very
limited. The PET and MRI are performed during the hospital admission on the day
before the surgical procedure and requires no extra site visits. Because of the
MRA-examination a dose of intravenous gadolinium contrast medium is
administered, for which the standard protocol requires that the eGFR (renal
filtration capacity) is adequate, and this laboratory test is a standard
procedure in the preoperative work-up. No other requirement for the study have
to be met. The PET comes with a radiation exposure of 2.7 mSv.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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 is obtained
Exclusion criteria
Technical impairments to perform the study
* Incapacity to lie in prone position for 60 minutes
* Aneurysm size smaller than PET detection rate (<7 mm)
* Physical restrictions, e.g. morbid obesity
* Claustrophobia
o Evidence of active infection requiring antibiotic therapy
o Pregnancy or lactation
o Renal insufficiency (estimated glomerular filtration rate < 60
ml/min/1.73 m2)
o Known allergy to gadolinium contrast agent
o Patients with pacemakers, defibrillators, other implanted electronic
devices, or possible metal particles
o Treatment with metformin
o Multiple myeloma (Kahlers disease)
o Waldenstrom macroglobulinemia
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 |
|---|---|
| EudraCT | EUCTR2017-002183-41-NL |
| CCMO | NL52624.042.17 |