PET-imaging of Unruptured Intracranial Aneurysm Inflammation

Study Overview
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Brief Summary
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The main purpose of this study is to determine if PET-imaging can be used to evaluate inflammation level of intracranial aneurysms, thus helping to evaluate the rupture risk of intracranial aneurysm.

Detailed Description
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Study subjects are patients who are diagnosed with an unruptured saccular intracranial aneurysm and planned for elective surgical treatment of intracranial aneurysms. Prior the planned surgery, all study subjects will undergo PET-imaging of the brain with 18F-FDG- and 68Ga-DOTANOC-tracers targeting glucose metabolism and somatostatin receptors in inflammatory cells. After PET-imaging, samples for histopathological examination from the intracranial aneurysm sac will be collected during the surgery from every study subject. Blood samples are collected prior to aneurysm operation from the routine pre-operative laboratory tests. Cerebrospinal fluid samples are collected during the surgical procedure from the surgical site. From blood samples we will evaluate expression of 20 different circulating microRNAs (miRNA) and the level of tumor necrosis factor-1, interleukin 1 beta, vascular endothelial growth factor, and evaluate correlations between miRNA expression and SUVmax in PET-imaging and miRNA and aneurysm histological findings. Correlation between inflammatory findings in histological studies and PET-imaging will be evaluated (correlation of SUVmax to aneurysm histological findings).

Official Title
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PET-imaging of Unruptured Intracranial Aneurysm Inflammation

Conditions
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Intracranial Aneurysm, Cerebral Aneurysm, Inflammation

Intervention / Treatment
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* Radiation: PET imaging, 18F-FDG
* Radiation: PET imaging, 68Ga-DOTANOC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fusiform intracranial aneurysms Following medications: Asetylsalisylic acid or non-steroidal anti-inflammatory drugs. Patients who have contraindication for magnetic resonance imaging (Pace Makers, foreign ferromagnetic bodies or implants) Patients who are allergic to contrast agents. Pregnancy Underage persons Patients on somatostatin analogue medication or with known neuroendocrine tumor Exclusion Criteria: Patients who are diagnosed with unruptured intracranial aneurysm with MRI/MRA or DSA Patients who are planned to undergo surgical treatment (ligation) of the intracranial aneurysm Age ≥18 and <75 years. Saccular intracranial aneurysm with maximum diameter ≥ 3 mm.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET-IA<br>68Ga-DOTANOC 18F-FDG | Radiation: PET imaging, 18F-FDG<br>* PET-MRI with 18F-FDG<br>Radiation: PET imaging, 68Ga-DOTANOC<br>* PET-CT with 68Ga-DOTANOC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET-imaging of unruptured intracranial aneurysms | Uptake of 18F-FDG or 68Ga-DOTANOC in intracranial arterial aneurysms as compared to contra-lateral normal vessel as SUVmax or TBR. Correlation of uptake of 18F-FDG or 68Ga-DOTANOC (SUVmax or TBR) to aneurysm histological findings (CD45, CD3, CD5, CD20, CD138 and CD68, SSTR2, SSTR3 and SSTR5) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for intracranial aneurysm inflammation | Uptake of 18F-FDG or 68Ga-DOTANOC and histological findings correlation to aneurysm size and shape, smoking, hypertension, location of aneurysm. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET, intracranial aneurysm, inflammation, positron emission tomography, rupture risk