PET-imaging of Unruptured Intracranial Aneurysm Inflammation
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- PET-imaging of unruptured intracranial aneurysms
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
PET-imaging of unruptured intracranial aneurysms
时间窗: 1 month
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)
次要结局
- Risk factors for intracranial aneurysm inflammation(1 month)
研究者
Jaakko Rinne
Professor
Turku University Hospital