PET-imaging of Unruptured Intracranial Aneurysm Inflammation
PET-IA
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2021
CompletedStudy Start
First participant enrolled
January 14, 2021
CompletedFirst Posted
Study publicly available on registry
January 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedJanuary 20, 2021
January 1, 2021
12 months
January 14, 2021
January 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
1 month
Secondary Outcomes (1)
Risk factors for intracranial aneurysm inflammation
1 month
Study Arms (1)
PET-IA
EXPERIMENTAL68Ga-DOTANOC 18F-FDG
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Turku University Hospitallead
- University of Turkucollaborator
Study Sites (1)
Turku University Hospital
Turku, 20521, Finland
Related Publications (1)
Laukka D, Paturi J, Rahi M, Saraste A, Parkkola R, Kivelev J, Gardberg M, Kuhmonen J, Rinne J. PET imaging of unruptured intracranial aneurysm inflammation (PET-IA) study: a feasibility study protocol. BMJ Open. 2024 Feb 20;14(2):e076764. doi: 10.1136/bmjopen-2023-076764.
PMID: 38382960DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 14, 2021
First Posted
January 20, 2021
Study Start
January 14, 2021
Primary Completion
January 1, 2022
Study Completion
October 1, 2022
Last Updated
January 20, 2021
Record last verified: 2021-01