PET-imaging of Unruptured Intracranial Aneurysm Inflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-14

Study Completion Date

2022-10-31

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.

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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).

Conditions

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Intracranial Aneurysm Cerebral Aneurysm Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PET-IA

68Ga-DOTANOC 18F-FDG

Group Type EXPERIMENTAL

PET imaging, 18F-FDG

Intervention Type RADIATION

PET-MRI with 18F-FDG

PET imaging, 68Ga-DOTANOC

Intervention Type RADIATION

PET-CT with 68Ga-DOTANOC

Interventions

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PET imaging, 18F-FDG

PET-MRI with 18F-FDG

Intervention Type RADIATION

PET imaging, 68Ga-DOTANOC

PET-CT with 68Ga-DOTANOC

Intervention Type RADIATION

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes