PET-imaging of Unruptured Intracranial Aneurysm Inflammation

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Brief Title

PET-imaging of Unruptured Intracranial Aneurysm Inflammation

Official Title

PET-imaging of Unruptured Intracranial Aneurysm Inflammation

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 Type

Interventional


Primary Outcome

PET-imaging of unruptured intracranial aneurysms

Secondary Outcome

 Risk factors for intracranial aneurysm inflammation

Condition

Intracranial Aneurysm

Intervention

PET imaging, 18F-FDG

Study Arms / Comparison Groups

 PET-IA
Description:  68Ga-DOTANOC 18F-FDG

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

20

Start Date

January 14, 2021

Completion Date

October 2022

Primary Completion Date

January 2022

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.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jaakko Rinne, MD, Prof., +358 2 313 2799, [email protected]

Location Countries

Finland

Location Countries

Finland

Administrative Informations


NCT ID

NCT04715503

Organization ID

T225/2020


Responsible Party

Principal Investigator

Study Sponsor

Turku University Hospital

Collaborators

 University of Turku

Study Sponsor

Jaakko Rinne, MD, Prof., Principal Investigator, Turku University Hospital, Neurocenter, Department of Neurosurgery, Division of Clinical Neurosciences, University Of Turku


Verification Date

January 2021