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


- candidate number21674
- NTR NumberNTR5024
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-feb-2015
- Secondary IDsUMCG 201500130
- Public TitlePET-CTA ter Registratie van Inflammatie in de Vaatwand van IntracraniŽle Aneurysmata (PRIVIA-studie)
- Scientific TitlePET-CTA for Registration of Inflammation in the Vascular wall of Intracranial Aneurysms [PRIVIA]
- ACRONYMPRIVIA
- hypothesisT-cell inflammation in the vascular wall of an asymptomatic intracranial aneurysm can be accurately detected with 18F-IL2 PET-CTA (proof-of-concept).
- Healt Condition(s) or Problem(s) studiedAneurysm, Intracranial aneurysm
- 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/ĶL)
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
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-apr-2015
- planned closingdate1-jan-2017
- Target number of participants10
- Interventions18F-IL2 PET-CTA
- Primary outcomePrediction of inflammation by 18F-IL2 PET-CTA, related to the gold standard of histopathological examination (proof-of-concept).
- Secondary outcomeBlinded analysis of interobserver variability in 18F-IL2 PET-CTA interpretation.
- TimepointsNone
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. J.M.C. van Dijk
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Healthy Aging Pilots UMCG
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD11-feb-2015 - 12-apr-2015


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