Exploratory study for feasibility of MR macrophage imaging with Fermoxytol in patients with unruptured cerebral aneurysms - MR macrophage imaging study for unruptured cerebral aneurysms

Shiga University of Medical Science0 个研究点目标入组 60 人开始时间: 2015年5月12日最近更新: 2023年10月17日

试验速览

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•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 equal or more than 1000 ng/mL 10)History of allergy to drugs including iron preparations 11)Current use of other iron preparations 12)Current treatment for or past history of liver disease 13)Renal failure or multiple comorbidities 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

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