Skip to main content
Clinical Trials/NCT04715503
NCT04715503
Unknown
Not Applicable

PET-imaging of Unruptured Intracranial Aneurysm Inflammation

Turku University Hospital1 site in 1 country20 target enrollmentJanuary 14, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intracranial Aneurysm
Sponsor
Turku University Hospital
Enrollment
20
Locations
1
Primary Endpoint
PET-imaging of unruptured intracranial aneurysms
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 14, 2021
End Date
October 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jaakko Rinne

Professor

Turku University Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

PET-imaging of unruptured intracranial aneurysms

Time Frame: 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 Outcomes

  • Risk factors for intracranial aneurysm inflammation(1 month)

Study Sites (1)

Loading locations...

Similar Trials