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PET-CTA ter Registratie van Inflammatie in de Vaatwand van Intracraniële Aneurysmata (PRIVIA-studie)

PET-CTA for Registration of Inflammation in the Vascular wall of Intracranial Aneurysms [PRIVIA]

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29257
Enrollment
10
Registered
2015-02-11
Start date
2015-04-01
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

Unruptured intracranial aneurysm

Interventions

18F-IL2 PET-CTA

Sponsors

UMC Groningen
Lead Sponsor

Eligibility

Inclusion criteria

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

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 (1.5) - Contra-indications to 18F-IL2 PET-CTA o Technical impairments to perform the study &#61607; Incapacity to lie still for 30 minutes &#61607; Physical restrictions, e.g. morbid obesity &#61607; 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 outcomes

Primary

MeasureTime frame
Prediction of inflammation by 18F-IL2 PET-CTA, related to the gold standard of histopathological examination (proof-of-concept).

Secondary

MeasureTime frame
Blinded analysis of interobserver variability in 18F-IL2 PET-CTA interpretation.

Contacts

Public ContactJ.M.C. van Dijk

UMC Groningen

j.m.c.van.dijk@umcg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)