PET-imaging of Unruptured Intracranial Aneurysm Inflammation

Inflammation Clinical Trial

— PET-IA  

Official title:

PET-imaging of Unruptured Intracranial Aneurysm Inflammation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04715503
• Other study ID #: T225/2020
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: October 2022

Study information

• Verified date: January 2021
• Source: Turku University Hospital
• Contact: Dan Laukka, MD
• Phone: +358 2 313 2799
• Email: dan.laukka[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Inflammation
• Intracranial Aneurysm

Intervention

Radiation:
• PET imaging, 18F-FDG
PET-MRI with 18F-FDG
• PET imaging, 68Ga-DOTANOC
PET-CT with 68Ga-DOTANOC

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 month