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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000016359
• Date of registration: 30/01/2015
• Prospective Registration: Yes
• Primary sponsor: Shiga University of Medical Science
• Public title: Exploratory study for feasibility of MR macrophage imaging with Fermoxytol in patients with unruptured cerebral aneurysms
• Scientific title: Exploratory study for feasibility of MR macrophage imaging with Fermoxytol in patients with unruptured cerebral aneurysms - MR macrophage imaging study for unruptured cerebral aneurysms
• Date of first enrolment: 2015/01/30
• Target sample size: 60
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018997
• Study type: Observational
• Study design: Not selected Not selected
• Phase: Phase II

Countries of recruitment

Japan

Contacts

• Name: Yukiko Itaya
• Affiliation: Shiga University of Medical Science Hospital Clinical research center

• Name: Kazuhiko Nozaki
• Affiliation: Shiga University of Medical Science Department of Neurosurgery

Key inclusion & exclusion criteria

Inclusion 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

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

unruptured cerebral aneurysms

Primary Outcome(s)

Positive or negative assessment by aneurysm size based on macrophage imaging using MR T2* imaging

Secondary Outcome(s)

Quantification of brightness on the images obtained with macrophage imaging Adverse events

Source(s) of Monetary Support

Kyoto University Graduate School of Medicine

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 30/09/2015