PET-imaging of Unruptured Intracranial Aneurysm Inflammation

Not Applicable

• Conditions: Intracranial Aneurysm; Inflammation; Cerebral Aneurysm
• Interventions: Radiation: PET imaging, 18F-FDG; Radiation: PET imaging, 68Ga-DOTANOC

• Registration Number: NCT04715503
• Lead Sponsor: Turku University Hospital

Brief Summary

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

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).

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01-14
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Last Update Submitted: 2021-01-14
• Study First Posted: 2021-01-20
• Last Update Posted: 2021-01-20
• Primary Completion: 2022-01
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET-IA	PET imaging, 18F-FDG	68Ga-DOTANOC 18F-FDG
PET-IA	PET imaging, 68Ga-DOTANOC	68Ga-DOTANOC 18F-FDG

Primary Outcome Measures

Name	Time	Method
PET-imaging of unruptured intracranial aneurysms	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland