unruptured cerebral aneurysms
Conditions
Interventions
None listed
Sponsors
Shiga University of Medical Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria at the time of written informed consent are eligible for study entry. 1)An unruptured saccular cerebral aneurysm 3 mm or larger detected by MRA or 3D-CT angiography (including aneurysms 25 mm or larger and partially thrombosed aneurysms) 2)Age of 20 years or older at the time of informed consent 3)Written informed consent to participate in this study obtained from the patients themselves
Exclusion criteria
Exclusion criteria: 1)History of ruptured cerebral aneurysm 2)Multiple cerebral aneurysms (patients may be enrolled if the size of the concomitant aneurysm is smaller than 3 mm) 3)History of surgical treatment for cerebral aneurysm or intracranial disease 4)Past or current history of intracranial disease (intracerebral hemorrhage, cerebral infarction, brain tumor, head trauma) 5)Cerebral aneurysm developed secondary to vasculitis, vascular malformation, or other diseases 6)Special cerebral aneurysm called completely thrombosed giant aneurysm or giant fusiform aneurysm 7)Patients assessed to need immediate surgical treatment at the time of detection of unruptured cerebral aneurysm 8)Current use of anti-inflammatory drugs (e.g., NSAIDs, COX-2 inhibitors, steroids, statins) 9)Serum ferritin level of more than 1000 ng/mL 10)History of allergy to iron preparations 11)Current use of other iron preparations 12)Current treatment for or past history of liver disease 13)Renal failure 14)Hypotension with systolic blood pressure < 100 mmHg or treatment of hypotension 15)Pregnancy or childbearing potential 16)Lactation 17)Inability to undergo MRI due to the presence of a pacemaker, claustrophobia, or other reason 18)Difficulty in acquisition of MR images of the cerebral aneurysm due to artifacts or other reason 19)Patients assessed by the investigator to be ineligible for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive or negative assessment by aneurysm size based on macrophage imaging using MR T2* imaging | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantification of brightness on the images obtained with macrophage imaging Adverse events | — |
Countries
Japan
Contacts
Public ContactYukiko Itaya
Shiga University of Medical Science Hospital Clinical research center
Outcome results
None listed