PET for Registration of Inflammation of Intracranial Aneurysms

Phase 1

Active, not recruiting

• Conditions: intracranial aneurysm; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2017-002183-41-NL
• Lead Sponsor: MCG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-19
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age = 18 year
• Presence of an unruptured intracranial aneurysm
• Standard of care decision to treat the aneurysm
• The aneurysm is surgically accessible
• Aneurysm wall sampling is deemed possible by the surgeon
• Written informed consent is obtained
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Technical impairments to perform the study
? Incapacity to lie in prone position for 60 minutes
? Aneurysm size smaller than PET detection rate (<7 mm)
? Physical restrictions, e.g. morbid obesity
? Claustrophobia
o Evidence of active infection requiring antibiotic therapy
o Pregnancy or lactation
o Renal insufficiency (estimated glomerular filtration rate < 60
ml/min/1.73 m2)
o Known allergy to gadolinium contrast agent
o Patients with pacemakers, defibrillators, other implanted electronic
devices, or possible metal particles
o Treatment with metformin
o Multiple myeloma (Kahlers disease)
o Waldenstrom macroglobulinemia
o Myasthenia gravis
o Pheochromocytoma
o Mastocytosis
o Thyroid cancer
o Planned thyroid scan

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary Objective<br>Detection of inflammation by [18F]FB-IL2, related to the gold standard<br>of histopathological examination, molecular analysis, and (if applicable)<br>arterial wall characteristics on MRI (proof-of-concept).;Secondary Objective: Secondary Objective<br>Analysis of interobserver variability in [18F]FB-IL2 interpretation;Primary end point(s): Detection of inflammation by [18F]FB-IL2, related to the gold standard<br>of histopathological examination, molecular analysis, and arterial wall<br>characteristics on MRI (proof-of-concept).;Timepoint(s) of evaluation of this end point: Interobserver variability in [18F]FB-IL2 interpretation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Interobserver variability in [18F]FB-IL2 interpretation;Timepoint(s) of evaluation of this end point: After inclusion of all subjects