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PET-imaging of Unruptured Intracranial Aneurysm Inflammation (PET-IA)

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ClinicalTrials.gov Identifier: NCT04715503
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Collaborator:
University of Turku
Information provided by (Responsible Party):
Jaakko Rinne, Turku University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Cerebral Aneurysm Inflammation Radiation: PET imaging, 18F-FDG Radiation: PET imaging, 68Ga-DOTANOC Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET-imaging of Unruptured Intracranial Aneurysm Inflammation
Actual Study Start Date : January 14, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PET-IA
68Ga-DOTANOC 18F-FDG
 Radiation: PET imaging, 18F-FDG
PET-MRI with 18F-FDG

Radiation: PET imaging, 68Ga-DOTANOC
PET-CT with 68Ga-DOTANOC


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Risk factors for intracranial aneurysm inflammation [ Time Frame: 1 month ]
    Uptake of 18F-FDG or 68Ga-DOTANOC and histological findings correlation to aneurysm size and shape, smoking, hypertension, location of aneurysm.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715503


Contacts
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Contact: Dan Laukka, MD +358 2 313 2799 dan.laukka@tyks.fi

Locations
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Finland
Turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Dan Laukka, MD    +358 2 313 2799    dan.laukka@tyks.fi   
Principal Investigator: Jaakko Rinne, MD, Prof.         
Sub-Investigator: Dan Laukka, MD         
Sub-Investigator: Antti Saraste, MD, Prof.         
Sub-Investigator: Melissa Rahi, MD, PhD         
Sub-Investigator: Juri Kivelev, MD, PhD         
Sub-Investigator: Johanna Kuhmonen, MD, PhD         
Sub-Investigator: Riitta Parkkola, MD, Prof         
Sub-Investigator: Maria Gardberg, MD, PhD         
Sponsors and Collaborators
Turku University Hospital
University of Turku
Investigators
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Principal Investigator: Jaakko Rinne, MD, Prof. Turku University Hospital, Neurocenter, Department of Neurosurgery, Division of Clinical Neurosciences, University Of Turku
Study Director: Antti Saraste, MD, Prof. Turku University Hospital, Heart Centre, University of Turku
More Information
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Responsible Party: Jaakko Rinne, Professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT04715503    
Other Study ID Numbers: T225/2020
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jaakko Rinne, Turku University Hospital:
intracranial aneurysm
PET
inflammation
positron emission tomography
rupture risk
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Inflammation
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action