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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

Tracking Information
First Submitted Date  ICMJE January 14, 2021
First Posted Date  ICMJE January 20, 2021
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE January 14, 2021
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2021)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2021)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PET-imaging of Unruptured Intracranial Aneurysm Inflammation
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Intracranial Aneurysm
  • Cerebral Aneurysm
  • Inflammation
Intervention  ICMJE
  • Radiation: PET imaging, 18F-FDG
    PET-MRI with 18F-FDG
  • Radiation: PET imaging, 68Ga-DOTANOC
    PET-CT with 68Ga-DOTANOC
Study Arms  ICMJE Experimental: PET-IA
68Ga-DOTANOC 18F-FDG
Interventions:
  • Radiation: PET imaging, 18F-FDG
  • Radiation: PET imaging, 68Ga-DOTANOC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 14, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Dan Laukka, MD +358 2 313 2799 dan.laukka@tyks.fi
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04715503
Other Study ID Numbers  ICMJE T225/2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jaakko Rinne, Turku University Hospital
Study Sponsor  ICMJE Turku University Hospital
Collaborators  ICMJE University of Turku
Investigators  ICMJE
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
PRS Account Turku University Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP