PET-imaging of Unruptured Intracranial Aneurysm Inflammation (PET-IA)
Primary Purpose
Intracranial Aneurysm, Cerebral Aneurysm, Inflammation
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
PET imaging, 18F-FDG
PET imaging, 68Ga-DOTANOC
Sponsored by
About this trial
This is an interventional diagnostic trial for Intracranial Aneurysm focused on measuring intracranial aneurysm, PET, inflammation, positron emission tomography, rupture risk
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.
Sites / Locations
- Turku University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET-IA
Arm Description
68Ga-DOTANOC 18F-FDG
Outcomes
Primary Outcome Measures
PET-imaging of unruptured intracranial aneurysms
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
Risk factors for intracranial aneurysm inflammation
Uptake of 18F-FDG or 68Ga-DOTANOC and histological findings correlation to aneurysm size and shape, smoking, hypertension, location of aneurysm.
Full Information
NCT ID
NCT04715503
First Posted
January 14, 2021
Last Updated
January 14, 2021
Sponsor
Turku University Hospital
Collaborators
University of Turku
1. Study Identification
Unique Protocol Identification Number
NCT04715503
Brief Title
PET-imaging of Unruptured Intracranial Aneurysm Inflammation
Acronym
PET-IA
Official Title
PET-imaging of Unruptured Intracranial Aneurysm Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
University of Turku
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm, Cerebral Aneurysm, Inflammation
Keywords
intracranial aneurysm, PET, inflammation, positron emission tomography, rupture risk
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PET-IA
Arm Type
Experimental
Arm Description
68Ga-DOTANOC 18F-FDG
Intervention Type
Radiation
Intervention Name(s)
PET imaging, 18F-FDG
Intervention Description
PET-MRI with 18F-FDG
Intervention Type
Radiation
Intervention Name(s)
PET imaging, 68Ga-DOTANOC
Intervention Description
PET-CT with 68Ga-DOTANOC
Primary Outcome Measure Information:
Title
PET-imaging of unruptured intracranial aneurysms
Description
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)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Risk factors for intracranial aneurysm inflammation
Description
Uptake of 18F-FDG or 68Ga-DOTANOC and histological findings correlation to aneurysm size and shape, smoking, hypertension, location of aneurysm.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Laukka, MD
Phone
+358 2 313 2799
Email
dan.laukka@tyks.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaakko Rinne, MD, Prof.
Organizational Affiliation
Turku University Hospital, Neurocenter, Department of Neurosurgery, Division of Clinical Neurosciences, University Of Turku
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antti Saraste, MD, Prof.
Organizational Affiliation
Turku University Hospital, Heart Centre, University of Turku
Official's Role
Study Director
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Laukka, MD
Phone
+358 2 313 2799
Email
dan.laukka@tyks.fi
First Name & Middle Initial & Last Name & Degree
Jaakko Rinne, MD, Prof.
First Name & Middle Initial & Last Name & Degree
Dan Laukka, MD
First Name & Middle Initial & Last Name & Degree
Antti Saraste, MD, Prof.
First Name & Middle Initial & Last Name & Degree
Melissa Rahi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Juri Kivelev, MD, PhD
First Name & Middle Initial & Last Name & Degree
Johanna Kuhmonen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Riitta Parkkola, MD, Prof
First Name & Middle Initial & Last Name & Degree
Maria Gardberg, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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PET-imaging of Unruptured Intracranial Aneurysm Inflammation
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