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UnknownNCT04715503

PET-imaging of Unruptured Intracranial Aneurysm Inflammation

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Turku University Hospital · Other Government
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
RADIATIONPET imaging, 18F-FDGPET-MRI with 18F-FDG
RADIATIONPET imaging, 68Ga-DOTANOCPET-CT with 68Ga-DOTANOC

Timeline

Start date
2021-01-14
Primary completion
2022-01-01
Completion
2022-10-01
First posted
2021-01-20
Last updated
2021-01-20

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT04715503. Inclusion in this directory is not an endorsement.