PET for Registration of Inflammation of Intracranial Aneurysms

PET for Registration of Inflammation in the Vascular wall of Intracranial Aneurysms

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002183-41-NL

Enrollment

Registered

2017-07-19

Start date

2020-08-27

Completion date

Unknown

Last updated

2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intracranial aneurysm

Interventions

Product Name: [18F]FB-IL2 Pharmaceutical Form: Infusion INN or Proposed INN: interleukin-2 CAS Number: 110942-02-4 Other descriptive name: ALDESLEUKIN Concentration unit: µg microgram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Netherlands

Contacts

Public ContactDepartment neurosurgery

UMCG

0031503612837

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026